Meet Our Senior Associate

 

Senior Associate

Marie Rigley is a regulatory professional with over 12 years’ experience supporting and advising on medical device submissions,

Marie Rigley has more than a decade of experience as a regulatory professional supporting and advising on medical device submissions. She has led successful FDA engagements and interactions by leveraging her  scientific background to quickly grasp a wide variety of therapeutic areas and technologies with the goal of developing and implementing strategic regulatory objectives while simultaneously meeting evolving business needs.

Education & Specialities

 

  • BS, Biology

  • Cardiovascular, Respiratory, Surgical Implants, Face Masks, etc.

 

Career Highlights

-Began career in the medical device industry in R&D and moved to Quality and most recently focused on Regulatory Affairs

-Most Recent Role: Senior Quality and Regulatory Specialist with Confinis Corporation, a Swiss and US-based regulatory consulting firm

While at Confinis, Rigley advised clients on regulatory strategy, authored and led multiple pre-submissions and 510(k) submissions for various medical devices (cardiovascular, respiratory, surgical implants, face masks, etc.). She also evaluated both technical files/DHF and Quality Management Systems to identify any gaps in meeting FDA requirements, registered numerous clients for FDA Establishment and Device Listings, acted as their US Agent, and assisted on FDA import/export matters. Rigley also has experience assisting on combination product submissions (NDAs) for a pen-injector and an infusion pump as well as assisting with design control matters for a drug- eluting balloon stent for their PMA.

Marie Rigley resides in Michigan with my husband and two children (ages 13 and 11) and a lot of pets! She loves being outside, mostly just relaxing in the backyard with friends and family, going to the lake,fishing, swimming, or playing or watching sports with my family.

Marie Rigley’s Latest Insights

Understanding the LDT Proposed Rule: Actionable Insights for Medical Device Manufacturers 

In the realm of healthcare, accurate and reliable diagnostic tests are the cornerstone of patient care. The Food and Drug Administration (FDA), as the regulatory authority overseeing medical devices and diagnostics, has recently voiced concerns about the reliability of Laboratory Developed Tests (LDTs). In order to properly address such concerns revolving around LDTs, the FDA is now poised to begin reshaping the way clinical laboratories develop, validate, and market diagnostic tests with their Laboratory Developed Test (LDT) Proposed Rule.