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Anupama Wenzel

@anupamawenzel

Senior Regulatory Affairs Specialist at Class III med device company, FDA PMA and MDR device dossiers regulatory submissions.

United States

Message

What I'm looking for

I'm pursuing a Principal Regulatory Affairs Specialist or Regulatory Affairs Project Management role that presents professional challenges and lets me apply my problem-solving expertise.

At LeMaitre Vascular, Inc, I authored EU MDR and UK MDR initial device dossiers and change notices for disposable vascular tools and tissue implants. I also developed regulatory strategies for product changes involving sterilization, packaging, labeling, and materials.

At Advanced Bionics, LLC, I authored and co-authored FDA PMA supplements, annual reports, and 30-Day Notices for the Cochlear Implant. As a regulatory project leader, I coordinated subject matter experts responding to submission deficiencies.

Earlier, I assisted with 510(k) submissions at Trigg Laboratories and supported Special 510(k) submissions at Zonare. I hold a Master of Science in Biomedical Engineering and a Regulatory Affairs Certification US.

Experience

Work history, roles, and key accomplishments

Current

Senior Regulatory Affairs Specialist, II

Current

LeMaitre Vascular, Inc

Sep 2021 - Present (5 years)

Authored EU MDR/UK MDR device dossiers, Health Canada licence applications, and FDA submissions. Developed regulatory strategies for significant changes and served as SME for design control and risk management.

EU MDR UK MDR 2012 Health Canada Regulations FDA ESTAR 506J Design Control Risk Management Clinical Evaluation Reports Labeling SOPs

Senior Regulatory Affairs Specialist

Advanced Bionics, LLC

May 2017 - Sep 2021 (4 years 4 months)

Authored PMA supplements, annual reports, and 30-day notices for FDA, and licence applications for Health Canada. Served as regulatory core team member and project leader for submissions.

FDA PMA Health Canada Regulations Regulatory Submissions Project Management Change Notifications Engineering Change Orders (ECO'S)

Regulatory Affairs Specialist (Contract)

Trigg Laboratories

Jan 2016 - Jul 2016 (6 months)

Assisted with the authorship of two 510(k) submissions.

510(K)Regulatory Submissions

Document Control (Contract)

Trigg Laboratories

Aug 2015 - Dec 2015 (4 months)

Responsible for the document control system, writing and revising SOPs, and maintaining QMS documents and records.

Document Control SOPs QMS CAPA NCR DCO

Quality Systems Compliance Specialist

Zonare

Dec 2013 - Jul 2015 (1 year 7 months)

Managed the complaints process for the Quality Management System in compliance with ISO 13485 and 21 CFR 820. Assisted with Special 510(k) submissions.

ISO 13485 21 CFR 820 Complaint Handling 510(K)Quality Management Systems