Sarah Stec

Sarah H. Stec

Associate

Sarah Stec is an associate in the Public Policy Practice in Washington DC. She has experience in assisting life sciences companies, including medical device and pharmaceutical companies, understanding new and evolving regulatory duties, including how those international regulations can work together, as well as providing guidance on international corporate accreditation and regulatory issues. Her unique approach to regulatory issues incorporates a deep understanding in the corresponding legal and quality issues, providing well-rounded solutions to clients in heavily regulated life sciences industries.

Sarah is a member of the Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI). Sarah is a faculty member at FDA to train new hires at FDA-CDRH on FDA regulations, and has extensive experience training industry and international regulators on both the EU and US FDA regulations. She regularly attends and speaks at international medical device and pharmaceutical regulatory conferences. She has a Regulatory Affairs Certification (RAC), covering regulations dealing with medical devices, pharmaceuticals, and biologics in the European Union.

Explore

  • Seconded to specialty pharmaceutical company as legal and compliance team leader for orphan drug launch, identifying and planning legal needs for the supply chain, regulatory, quality and commercial organizations.
  • Building procedures and advising on cross-border labeling, regulatory, quality, medical affairs and advertising issues for pharmaceutical and medical device manufacturers.
  • Monitoring worldwide regulatory developments and providing regulatory updates and addressing compliance obligations and emerging industry developments.
  • Advising on and drafting clinical trial agreements for multisite, international clinical trials for drugs and medical devices.
  • Translating the EU and FDA pre-approval, clinical trial, Research Use Only, Investigative Device Exception and other regulations for clients on both sides of the Atlantic to provide regulatory guidance and help clients develop regulatory strategies.
  • Primary resource for guidance on EU Medical Devices Directive (93/42/EC), Active Implantable Medical Devices Directive (90/385/EEC), In Vitro Diagnostic Medical Devices Directive (98/79/EC), ISO 13485, and others, and how they compare with US FDA 510(k) and PMA regulations, US FDA Quality System regulations, Universal Device Identifier regulations, labeling and advertising laws.
  • Interfacing with international regulators for questions concerns regarding client products.
  • Identifying and managing front-end research for all new domestic and international corporate accreditations, including OSHA NRTL, INMETRO (Brazil), COFEPRIS (Mexico).
  • Analyzing impacts of new notified body regulations on production capacities and bottom line.

Education

  • Pennsylvania State University, J.D., 2010
  • Loyola University Chicago, B.A., Honors, 2006

Admissions

  • Virginia, 2011
  • Not admitted in the District of Columbia; practice limited to matters pending at federal courts and agencies.

Memberships and Affiliations

  • Member of the Regulatory Affairs Professionals Society (RAPS) 
  • Member of the Food and Drug Law Institute (FDLI)

Languages

  • English
  • French

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  • Faculty Member, FDLI training for new CDRH staff members and reviewers, Overview of US Medical Device Regulations session, June 2017.
  • Speaker, “EU Medical Device Regulation,” FDLI Annual Conference, May 2017.
  • Speaker, “Adverse Event Reporting for Healthcare Facilities,” Squire Patton Boggs Webinar, December 2016.
  • Speaker, “US FDA Regulations Overview,” LNE/G-MED Medical Device Forum, December 2016.
  • Co-author, “EU Agrees on New Medical Device and IVD Regulation,” Food and Drug Law Institute Update Magazine, November/December 2016.
  • Speaker, “US Medical Device Regulatory Essentials Workshop – Advertising and Promotion of Medical Devices,” RAPS Convergence, September 2016.
  • Speaker and Moderator, “Market Access and Reimbursement for Medical Devices; Intellectual Property Strategies at All Stages; Usability and Interoperability of Software Medical Devices,” RAPS Convergence, September 2016.
  • Speaker, “Overview of FDA Guidance Documents,” BioOhio Regulatory Forum, September 2016.
  • Moderator, “Common Challenges Facing Lawyers in our Globalized Medical Products Industry, Parts 1 and 2; Advertising, Promotion, and the Sunshine Act,” RAPS Regulatory Convergence, October 2015.
  • Author, Chapter on Enforcement and National Authorities, Fundamentals of EU Regulatory Affairs, 7th Edition.
  • Presenter, “EU IVD Regulatory Evolutions on Performance Evaluations and Post-Market Surveillance,” Q1 Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 2015.
  • Presenter, “Update on EU IVD and Medical Device Regulations,” BioOhio Conference, Columbus, Ohio, September 2015.
  • Presenter, “Best Practices for Unannounced Audits,” Q1 Productions Webinar, October 2014.
  • Speaker, “Changes to IVD and EU Regulations,” BioOhio Regulatory Forum, October 2014.
  • Moderator, “EU IVD Regulatory Evolutions, Product Sampling During Unannounced Audits,” RAPS Convergence, October 2014.
  • Speaker, “Communication for Regulatory Managers,” RAPS Regulatory Manager’s Bootcamp, September 2014.
  • Speaker and Moderator, “EU Regulatory Basics, Unannounced Audits,” G-MED Client Forum, October 2014.
  • Trainer, “US FDA Regulations,” G-MED Training for SFDA, August 2014.
  • Co-author, “Regulatory Evolutions for Medical Devices in the EU,” Food and Drug Law Institute Update Magazine, July/August 2013.