2023 Speakers

Nelson Anderson

Nelson Anderson is a biomedical engineer and IT product owner at the FDA. He was a lead reviewer in CDRH for cardiovascular devices for 13 years before moving into the IT realm 7 years ago and is now the platform owner for the CDRH Portal among other duties. Nelson has maintained his sanity through 20 years in the federal government by traveling and geocaching around the world, having recently returned from climbing Kilimanjaro.

Blake Bevill, Program Division Director

Division 2, Office of Medical Device and Radiological Health Operations

Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014. He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations. As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO. He graduated from Harding University with a Bachelor’s degree in Biology, Arkansas State University with a Master’s of Science degree in Biology, and completed a Senior Executive Development program at George Washington University.

Johnathon Bis

Johnathon (John) Bis is the Commercial Operations Director, Regulatory Services – Americas for BSI. BSI is a leading Notified Body for the European Union Medical & Invitro Devices Regulations as well as UKCA, ISO 13485, MDSAP and Standards. He is responsible for leading the commercial operations team to support client needs while ensuring BSI’s values are upheld.

Over the past 10+ years John has led a highly talented team of business development managers who help our clients achieve excellence in the healthcare market. John is driven to ensure BSI clients are provided quality services that include but not limited to; Assessments, CE Marking, Training, Resource Tools and Technical Expertise that ensure that our clients succeed in regards to bringing quality products to the healthcare market. Over the past 10+ years John has led a highly talented team of business development managers who help our clients achieve excellence in the healthcare market.

John has over 31 years of experience in the Healthcare industry. John collaborates with professionals and organizations who serve the medical industry world-wide.

Mark Chan

Mark Chan is a Medical Device Recall Coordinator under the Office of Devices and Radiological Health Operations (OMDRHO)/Division 3-West.  He started his FDA career as a Consumer Safety Office in Los Angeles District in April 1991 and transferred to the San Francisco District/San Jose Resident Post in 1992.  Through his 32-year career with the US Food & Drug Administration, Mark spent 28 years within Investigations Branch conducted numerous inspections specifically in the medical device area.  In 1995-1996, Mark became a member of the DCIS (Design Control Inspectional Strategy) Team to assist with developing the QSIT (Quality System Inspectional Technique) guidance and was a member of the Medical Device Foreign Cadre conducting inspections in Europe and Asia. In 2000, Mark became the Medical Device Specialist for the San Francisco District.  In 2019, Mark became one of three Division Recall Coordinators within OMDRHO/Division 3-West.  Mark earned his bachelor’s degree in Biological Sciences from the University of California, Berkeley.

Frances Cohen

Frances Cohen is President of Promenade Software Inc., a leading software services firm specializing in medical device and safety-critical system software. Frances has more than 20 years of experience leading software teams for medical device software. Starting with heart defibrillators for Cardiac Science and following with Source Scientific LLC and BIT Analytical Instruments Inc., Frances has overseen dozens of projects through development and the FDA, including IDEs, 510(k)s, and PMAs.

Frances has a B.S. in computer engineering from the Technion, Israel Institute of Technology.

John Doucet, PhD

Vice President of Regulatory Affairs – Neuromodulation and Evolving Technologies

MCRA

Dr. Doucet joined MCRA on August 31^st, 2020 and provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies. He has extensive knowledge of medical device regulatory pathways to drive technologies from conception to market. John is a neuroscientist and biomedical engineer with 3+ years of consulting experience for the medical device industry,  10+ years of FDA experience in medical device regulation, 13+ years of Johns Hopkins experience in discovery science, and 9+ years of management experience at MCRA, FDA, and Johns Hopkins School of Medicine.

Prior to joining MCRA, Dr. Doucet was the Former US Food and Drug Administration (FDA) Policy Lead, for the Breakthrough Device Program. In this position, Dr. Doucet managed the Breakthrough Device Program, where he oversaw all aspects of the program, was involved in the granting or denial of all Breakthrough designation requests, and served as CDRH’s expert for internal and external stakeholders regarding the regulatory standard for obtaining the Breakthrough designation for a medical device.

In addition to Dr. Doucet’s leadership role with the FDA Breakthrough Designation Device Program, John also served in additional roles at FDA including Acting Director of IDE Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation.

Erica M. Katherine

With over a decade of experience, Erica M. Katherine has been a dedicated leader in the multifaceted fields of regulatory affairs and ombudsman practice. Serving as the Ombudsman for the FDA Office of Regulatory Affairs (ORA) since 2019, she is committed to helping stakeholders navigate intricate regulatory landscapes, resolve conflicts, and foster positive relationships.

Erica began her career with the FDA in 2008 as an investigator in the New Orleans District, where she conducted inspections of food, drug, and medical device firms while also reviewing and examining import shipments. In 2012, she advanced to the role of a compliance officer in the Florida District, managing cases across various program areas and actively contributing to the development of ORA procedures. Her exceptional performance led to her being named the Compliance Officer of the Year in 2016, recognizing her outstanding work with a substantial impact at both the local and national levels.

Erica’s dedication extends beyond her role as an ombudsman. She served on the Coalition of Federal Ombudsman Executive Committee from 2020 to 2022 and is presently the co-chair of the United States Ombudsman Association Federal Chapter. Erica holds a Master of Science in Biotechnology with a focus on Regulatory Affairs from the University of Maryland University College and a Bachelor of Science in Chemistry from Jackson State University, providing a well-rounded educational foundation that complements her extensive experience in the regulatory and ombudsman professions.

Allison Komiyama

Allison is a regulatory consultant focused on FDA submissions for the medical device industry. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. Her previous company (AcKnowledge Regulatory Strategies, LLC) that she founded in 2014 was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle. Much of her recent work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about Regulatory Submissions as a faculty member at UCSD extension. She was an FDA reviewer for a brief stint from 2010-2011 and received her Regulatory Affairs Certification (US) in 2014.  

Evangeline Loh, Ph.D.

Evangeline Loh, Ph.D., RAC (US, EU) , Emergo by UL, Manager, Global Quality & Regulatory AffairsDuring her over 17 year tenure at Emergo by UL, Evangeline has assisted hundreds of manufacturers with global regulatory strategy, registration and consulting projects. Evangeline’s areas of expertise include European CE Marking, clinical evaluation reports, and now performance evaluation reports, global vigilance, and device classification in markets worldwide. She has been intimately involved in the EU transition from the Directives to the Regulations, and all the related regulatory requirements. Evangeline is a key architect in developing tools for Emergo’s Regulatory Affairs Management Suite (RAMS) software. She has most recently been tasked with advancing the organization’s Thought Leadership presence, as well more visibly sharing Emergo by UL’s global regulatory expertise.  She previously worked for Cook Medical as a regulatory scientist and at a non profit lobbying for medical schools. She has her Regulatory Affairs Certification (RAC), US and EU, in the days before there were discipline specific RACs, holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio, and a B.S. in microbiology from Cornell University. While she would purport that has no spare time, if she did, she would enjoy contemplating methods of how to be more efficient, working-out as a means to enjoy food, and traveling for leisure.

Mary A. Millner

LCDR Mary Millner is a Medical Device Specialist in ORA’s Office of Medical Device and Radiological Health Operations (OMDRHO), Division 2. She is also a commissioned officer in the U.S. Public Health Service and is stationed in Nashville, TN. LCDR Millner has been performing medical device inspections since joining FDA in 2014 and has served multiple details as a Supervisory Consumer Safety Officer, Compliance Officer, and Recall Coordinator. LCDR Millner earned her bachelor’s degree in Biomedical Engineering from St. Louis University and her master’s degree in Bioengineering from the Georgia Institute of Technology.

Alan Minsk

Alan Minsk is a partner and leader of the Food & Drug practice team at Arnall Golden Gregory, LLP. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, and food (including dietary supplements) companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration. Alan has been recognized frequently by Who’s Who Legal, Best Lawyers, and Chambers USA. Alan currently serves on the editorial boards for the Food and Drug Law Institute’s (FDLI) Food and Drug Law Journal and Regulatory Affairs Professionals Society’s (RAPS) Regulatory Focus publications.

Melissa O’Connor

Melissa O’Connor, M.S., FRAPS, RAC, CTBS has more than 20 years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization.  She has experience in Quality System design, implementation, maintenance, and compliance.  Melissa has held Quality and Regulatory leadership positions serving as the Management Representative, Head of Quality and official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc, a global manufacturer of adhesive based Class II medical devices for would closure.  During an 11-year tenure with Kimberly-Clark Health Care, Melissa held positions in Regulatory Affairs, Product Development, and Process Engineering.  In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development including pre-market approval requirements for U.S. and E.U.  She is a member of the Regulatory Affairs Professional Society (RAPS), holds an active RAC certification and was awarded the distinction of RAPS Fellow (FRAPS) in 2022.  Melissa holds a B.S. degree in Biological Sciences from the University of Georgia and an M.S. Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs. 

Melissa is a Certified Tissue Banking Specialist, an active individual member of the American Association of Tissue Banks (AATB) and is currently holds the elected position of 2023-2025 AATB Board of Governors Member-at-Large.  Melissa serves on the Living Donor Council of AATB, where she is the head of the Living Donor Regulatory Legislative Workgroup and functions as the bridge between the LDC Regulatory Workgroup and the Tissue Policy Group (TPG).  She is an active member of the TPG where she provides input into current regulatory and legislative issues and advocates on behalf of the entire tissue banking community to save and improve lives by promoting the safety, quality and availability of donated human tissue.

Melissa is a founding member and currently serves as the Chief Quality and Regulatory Officer for StimLabs, LLC, a regenerative medicine company based in Roswell, Georgia.  In her current role, Melissa is responsible for all aspects of Quality and Regulatory Affairs for StimLabs including Quality Assurance, Quality Control, Quality Engineering, Quality Management Systems, Donor Services, Donor Acquisition as well as tactical and strategic regulatory compliance and pre- and post-market submissions. 

Mark R. Prausnitz

Mark R. Prausnitz is Regents’ Professor, Regents’ Entrepreneur, and J. Erskine Love, Jr. Chair in Chemical & Biomolecular Engineering at the Georgia Institute of Technology. He carries out research on biophysical methods of drug delivery using microneedles, lasers, ionic liquids, and other microdevices for transdermal, ocular, and intracellular delivery of drugs and vaccines. He has published more than 330 journal articles and has co-founded eight start-up companies including Micron Biomedical and Clearside Biomedical.

Helin Räägel, PhD

Dr. Helin Räägel is the scientific thought leader and a senior biocompatibility expert for the Expert Advisory Services division within Nelson Labs. Her work focuses on assisting medical device manufacturers to find creative and scientifically sound solutions in their approach to biological evaluations targeted for regulatory submissions around the world. She is an active member of ASTM and ISO working groups focusing on biological safety assessments. She is passionate about the intersection of science and biocompatibility and frequently contributes to the global conversation around the risk-based approach to medical device biocompatibility in the form of published articles and webinars.

Helin has a PhD in molecular cell biology. Her successful academic career was highlighted by an Alexander von Humboldt Fellowship in Germany, and later by a Marie Curie Fellowship, research awards which are competitive on a global scale.

Joseph (Robby) Robertson

Product and Technology Lead, Insights to Impact Team

UCB

Robby serves as the Product and Technology Lead for US Insights to Impact Team at UCB. He has been leading work in AI-based technology and has deep experience in Software Engineering and Data Science applied to the healthcare space, utilizing healthcare-related real-world evidence (EMR/HR), commercial, and customer behavior data.  Robby has been with UCB for the last 8 years. He has done extensive research in collaboration with leading academic institutions for predicting disease severity progression of Neurological diseases like epilepsy so that patients can be helped with early intervention with appropriate therapy. He has conducted pioneering work in advancing some of the research into a regulated Software As a Medical Device (SaMD) product in UCB’s exploration in this space. 

Currently, he is leading efforts to mature UCB’s understanding of the patient journey and the obstacles that patients and physicians face in finding the right diagnosis and treatment approach, particularly in rare or otherwise hard-to-diagnose diseases.

Prior to joining UCB, Robby served as Chief Data Scientist at Illuminate360; was Cofounder & Head of Insights at Saygent; and Director for Advanced Analytics Research at LivePerson. He holds an MCA and B.Sc. from PSG College of Technology in Coimbatore, India, and received his MS in Applied Statistics from Kennesaw State University.

Peter Shearstone

Peter Shearstone is Vice President of Global Quality Assurance and Regulatory Affairs for Thermo Fisher Scientific. He joined the company in July 2018. Headquartered in Waltham, Massachusetts, Thermo Fisher is the world leader in serving science; our mission is to enable our customers to make the world healthier, cleaner, and safer.

Peter has led global regulatory and quality organizations in some of the most complex, demanding and technically advanced areas of the healthcare industry, including Ciba Corning, Dade Behring, Abbott Diagnostics, Hospira, and Sysmex. During his 30 years of healthcare experience, Peter has held executive positions in regulatory and quality assurance functions and has performed key roles in the technical support, sales, operations and research and development (R&D) functions.

He builds on an organization’s greatest strengths by incorporating leading edge best practices around the highest standards of compliance and quality. Over the course of his career, he has built quality-centric and customer-focused cultures, improved employee engagement and empowerment, implemented innovative compliance solutions, increased efficient processes, and created organizational effectiveness programs. He has also improved infrastructure, production and quality system operations that resulted in better products, regulatory compliance, customer satisfaction and patient outcomes.

Peter is active in the advancement of the regulatory/quality science profession. He represents Thermo Fisher Scientific at number of healthcare industry groups, including the Medical Device Innovation Consortium (MDIC), the Regulatory Affairs Professional Society (RAPS), the American Association of Clinical Chemistry (AACC), the Clinical and Laboratory Standards Institute (CLSI) and the American Society for Quality (ASQ). In support of these organizations, he has served on industry-wide committees and shared his expertise as a speaker and panel member.

Peter began his career in biotechnology sales for a small startup in Boston in 1989. He holds a bachelor’s degree in biology from Salem State University in Salem, Massachusetts. A native of Taunton, Massachusetts, he currently resides in Lake Forest, Illinois.

Alex Smith

Alex Smith, director of regulatory science at Hogan Lovells. As a former process and software engineer at GlaxoSmithKline and human genome sciences, Alex’s primary practice at H&L involves assisting companies with medical device and pharmaceutical submissions that involve software such as ai/ml submissions and 21 CFR part 11 concerns.  During his time at Hogan Lovells, Alex has provided software architecture and lifecycle advice on a substantial variety of devices such as AI radiological imaging, 3d adaptive manufacturing, infusion pumps, and individualized vaccines involving AI when it comes to digital health.

Kimberly A. Trautman

Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.

David Van Houten

David Van Houten is an FDA Compliance Officer for the Medical Device and Radiological Health program area.  He’s been working for the FDA for the past 33 years; for the first 19 as an Investigator in the New York and New England areas, followed by six years as a Supervisor in Phoenix, AZ and Nashville, TN, and for the past eight years as a Compliance Officer in Nashville, TN.  He’s completed all of FDA’s Medical Device training courses, has conducted hundreds of domestic and foreign medical device inspections as an Investigator, and has reviewed numerous medical device inspection reports as a Supervisor and Compliance Officer.  He also achieved Level II Medical Device Certification in 2007, while an Investigator, and then again in 2017 while a Compliance Officer.

Qianqian Zhu

Qianqian is the Director of China/HK RA/QA at Intuitive Surgical, Inc., serving as a pivotal link between Intuitive’s RAQA department and the IntuFosun RAQA team—a joint venture between Intuitive and Fosun. She plays a crucial role in developing localization strategies, negotiating support, and executing plans for in-country manufacturing transfer, regulatory approvals, and registrations. Prior to her current role, she excelled as the Director of International Regulatory Affairs at Immucor, Inc., managing international regulatory requirements, including product registration, importation compliance, and post-market vigilance.
• 11+ years of working experience in global regulatory affairs, including China NMPA registration, covering type test and clinical trials
• Proven track record of Class III MD, IVD, and Drug approvals in China
• Worked with CMDE on the drafting and releasing of 10+ technical review guidance
• Worked with BIMT and NIFDC on various national standards and reference material development
• RAC Global certified in 2016
• Practiced Law and International Trade in China and the UAE prior to coming to the U.S.

Johnathon Bis

Johnathon (John) Bis is the Commercial Operations Director of Regulatory Services – Americas for BSI. BSI is a leading Notified Body for the European Union Medical & Invitro Devices Regulations as well as UKCA, ISO 13485, MDSAP, and Standards. He is responsible for leading the commercial operations team to support client needs while ensuring BSI’s values are upheld.

Over the past 10+ years, John has led a highly talented team of business development managers who help our clients achieve excellence in the healthcare market. John is driven to ensure BSI clients are provided quality services that include but not limited to; Assessments, CE Marking, Training, Resource Tools, and Technical Expertise that ensure that our clients succeed in regards to bringing quality products to the healthcare market. Over the past 10+ years, John has led a highly talented team of business development managers who help our clients achieve excellence in the healthcare market.

John has over 31 years of experience in the Healthcare industry. John collaborates with professionals and organizations who serve the medical industry worldwide.

Dr. Renishkumar Delvadia

ph, Ph.D., Office of New Drug Products\OPQ\CDER\FDA

Dr. Renishkumar Delvadia is an experienced professional in pharmaceutical sciences, specializing in drug-device combination products, particularly inhalation and nasal drug delivery systems. He holds a Ph.D. in Pharmaceutical Sciences from the Aerosol Research Lab at Virginia Commonwealth University. He worked at Office of Research and Standards in the Office of Generic Drugs, CDER, at the FDA for six years. There, he focused on developing product-specific recommendations for pulmonary drug products and managed both external and internal research projects aimed at developing novel predictive bioequivalence approaches for orally inhaled and nasal drug products. Since 2018, he has been serving as a Senior Reviewer at the Office of New Drug Products, OPQ, CDER, at the FDA. In this role, he evaluates CMC aspects of pharmaceutical products and often acts as the Application Technical Lead for NDAs, with a particular focus on complex inhalation, nasal, and autoinjector products. Dr. Delvadia has authored over 60 international publications and presentations, showcasing his extensive expertise in pharmaceutical sciences.

Michael Fisher

Michael Fisher is a professor of the practice at Georgia Tech in the Department of Biomedical Engineering since 2022.  Before this, he spent 25 years as a medical product development engineer with several large corporations and a few start-up companies.  His experience ranges from traditional medical devices to stem cell harvesting and tissue engineering.  He led four successful 510(k) products and is named on over 60 US patents.  Mr. Fisher’s experiences help him to educate students and professors about careers in medical product development and translation of research into clinical use.

Seppe de Gelas

Seppe De Gelas has been a part-time faculty member of the UGA International Biomedical Regulatory Sciences at the College of Pharmacy since 2016 mainly teaching process validation, and US & European Regulatory Affairs classes.  He is also on the planning committee of both the faculty MDRC & GMP conferences.

Trained as a peptide chemist at Brussels University he started his career in clinical research and moved quickly into the field of regulatory affairs and quality assurance in pharmaceutical and biological manufacturing plants.  After a +25-year career holding increasing responsibilities with major pharmaceutical companies, (including Bristol-Myers Squibb, UCB, Baxter, Lonza & GSK Vaccines) as well as smaller medical device start-ups, he currently holds the position of VP Regulatory Affairs & Quality Assurance at Hyloris Pharmaceuticals, a Belgian based, stock-listed company.

He is passionate about travelling and vintage architecture often combining both during his supplier audit programs.

Lisa G. Hawkins

Lisa G. Hawkins, CMQ/OE is a highly experienced regulatory and quality professional for FDA regulated industries.  Her industry experience includes working for start-ups, growing, and large companies, oftentimes assuming a number of extra roles as needed.  This extensive experience in cross-functional activities gives Lisa a unique perspective on efficient and robust integration of regulatory and quality requirements that are not only compliant, but also efficient for the affected groups. Lisa is an active member in a number of industry organizations including the American Society for Quality (ASQ) from whom she holds Certified Manager of Quality and Organizational Excellence certification.  She also participates in standards setting groups for AAMI, ASTM, and others.Recently Lisa has also been involved in the development and deliver of documentation for cell-cultured foods organizations as the industry and FDA work together to establish consistent standards for this novel technology.

Al Jacks

In addition to his role as an Academic Professional with the UGA Department of International Regulatory Affairs, Al Jacks is also Vice President of Quality Assurance at Axogen, Inc. a biotech company involved in peripheral nerve repair products.  Al has over 25 years of QA/RA experience, including serving in leadership roles at Glaxo, J&J, CR Bard, CorMatrix, Alimera Sciences, and VERO Biotech prior to Axogen.  He has successfully implemented multi-site global quality management systems that meet FDA and international compliance requirements for biologics, pharmaceuticals, medical devices, tissue products, and combination products and is passionate about developing students and professionals as they grow their careers in Quality Assurance and Regulatory Affairs.  

Clare A Matti, MA, MTOPRA

A Regulatory Affairs and Quality Assurance professional with broad experience in clinical trials evaluation of, and marketing approvals for, drugs, medical devices and biologics

Currently Associate Director for Regulatory Affairs with The FlexPro Group, a Network Partners Company. Works with client partners to ensure products and processes meet established regulatory standards by identifying the relevant standards, pinpointing shortfalls, developing corrective measures and implementing necessary changes. Prepares briefing documents for and leads meetings with regulatory agency personnel.

Formerly head of Regulatory and Quality at the Duke Clinical Research Institute at Duke University. Designed courses and was principal instructor for EU and Canada regulations for the North Carolina Regulatory Affairs Forum from 2003 until 2019.

Nick Morley

Nick is a Principal Scientist at Element Materials Technology responsible for providing technical support to new and existing pharma, med device, and consumer products customers in the field of extractables and leachables. As an Analytical Chemist, he has over 15 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He sits on several British Standards Institute (BSI) and European Standards (CEN) Committees as an E&L expert and has presented on numerous different topics at international conferences. Before joining Element Materials Technology, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas and was responsible for the E&L assessment of closure systems and manufacturing processes to ensure patient safety, product quality, and regulatory approval.

James Wabby

Global Head, Regulatory Affairs, Center of Excellence (COE) – Emerging Device Technologies and Combination Products, and Volwiler Senior Research Industry Fellow – Regulatory Science

AbbVie, Inc.

22+ years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. Regularly provide AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs

• CMC Global Dossiers/Global Device Regulatory Strategies
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• 21 CFR Part 3 and Part 4 – Combination Products, CE Marking, ISO 13485:2016/MDSAP
• International Regulatory Affairs
• Represent AbbVie as the U.S Agent regarding FDA matters for international medical device facilities

Actively participate in industry trade organizations and serve on standards committees.