Anupama Wenzel
Cleveland,OH
Summary
Biomedical Engineer with Regulatory Affairs Certification and over 15 years of experience in the regulated medical devices industry (active implantable medical devices, ultrasound, ICDs, pacemakers, lubricants, cochlear implants, and disposable & implantable vascular devices). Strengths include regulatory submissions for FDA, Health Canada, EU MDR (CE Mark), and UK MDR (UKCA Mark). Developed relationships with R&D, Project Management, and Product Development as a regulatory core team member (RA Project Lead) to bring products to market.
Pursuing a Principal Regulatory Affairs Specialist or Regulatory Affairs Project Management role that presents professional challenges and problem-solving expertise.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Senior Regulatory Affairs Specialist, II
LeMaitre Vascular, Inc
Burlington, MA
09.2021 - Current
- Authored 3 EU MDR/UK MDR Initial Device Dossiers (2 Class III and 1 Class I), and 3 change notices for disposable vascular tools and tissue implants.
- Authored 2 Class IV New Licence for Health Canada, 2 Class IV Licence Amendments (both approved without any questions), and 1 Annual Report for Health Canada
- Authored 1 Annual Report of FDA Class III device, 1 30-Day Notice, 2 Q-Submissions
- Created and revised multiple SOPs for global compliance, including FDA eSTAR and 506J Shortages
- Served as the Regulatory Affairs SME for Design Control and Phase Review, Risk Management File review, and Clinical Evaluation Reports
- Developed and implemented regulatory strategies for multiple significant changes (sterilization & packaging, labeling, and material changes) to facilitate timely product launches in global markets.
- Served as the Regulatory Affairs Labeling representative for initial label publications.
Senior Regulatory Affairs Specialist
Advanced Bionics, LLC
Valencia, CA
05.2017 - 09.2021
- Authored 2 180 day PMA Supplements, Co-authored 1 180 day PMA Supplement, 1 Real-Time PMA supplement, 3 Annual Reports, and 8 30-Day Notices to FDA for the Cochlear Implant.
- Authored Class III and Class II Licence Applications and Amendments to Health Canada for the active implantable medical devices (Cochlear Implant).
- Regulatory core team member for the multiple new development projects (pre-market), multiple sustaining projects (post-market), supplier change notifications (SPCN), and engineering change orders (ECOs).
- Coordinated subject matter experts (SMEs) as the regulatory project leader to respond to submission deficiencies during the application review process.
- Supported regulatory country managers as products were submitted to Europe, Latin America, Asia Pacific, and Middle East/North Africa.
Regulatory Affairs Specialist (Contract)
Trigg Laboratories
Valencia, CA
01.2016 - 07.2016
- Assisted with the authorship of two 510(k) submissions
Document Control (Contract)
Trigg Laboratories
Valencia, CA
08.2015 - 12.2015
- Responsible for the document control system. Wrote and revised SOPs. Organized, filed and maintained QMS documents (SOPs, WIs, Forms, Labels) and records (training, NCRs, DCOs, CAPAs).
Quality Systems Compliance Specialist
Zonare (acquired by Mindray)
Mountain View, California
12.2013 - 07.2015
- Responsible for the Complaints Process of the Quality Management System in compliance with ISO 13485 and 21 CFR 820. Subject matter expert (SME) for complaint resolution process during audits.
- Assisted with the assembly of Special 510(k) submissions, including Indications for Use and Software sections
Technical Support Engineer
Zonare (acquired by Mindray)
04.2012 - 12.2013
- Provided technical support for ultrasound products to clinical customers, sales and clinical technology consultants (CTC), third party repair service, and dealer service network. Worked with customers to determine root cause of problems and recommended appropriate solutions.
- Reviewed DHRs, investigated complaints, and summarized complaint reports for regulatory affairs/quality assurance.
Technical Services Engineer I
St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, California
06.2010 - 03.2012
- Clinical and technical interface between the medical community and the various Cardiac Rhythm Management Division departments, supplied independent clinical and technical support in response to field inquiries from physicians, health care professionals, patients, field sales, field clinical engineers, and technical staff. Provided such services on a 24/7, on-call basis, rotating with other Technical Services personnel.
- Analyzed device, lead, and ECG/EKG data to determine appropriate function, and wrote product performance complaints from field for failure analysis and product reporting.
- Reviewed and completed Product Reporting Event Review forms, Medical Device Reporting, and Customer Letters. Reviewed prospective IDE data prior to FDA submission. Reviewed product manuals, communiqués and memorandums for technical/clinical accuracy and content.
Technical Services Engineering Specialist
St. Jude Medical Cardiac Rhythm Management Division
Sunnyvale, California
10.2005 - 06.2010
- Clinical and technical interface between the medical community and the various Cardiac Rhythm Management Division departments, supplied independent clinical and technical support in response to field inquiries from physicians, health care professionals, patients, field sales, field clinical engineers, and technical staff. Provided such services on a 24/7, on-call basis, rotating with other Technical Services personnel.
- Analyzed device, lead, and ECG/EKG data to determine appropriate function, and wrote product performance complaints from field for failure analysis and product reporting.
- Reviewed and completed Product Reporting Event Review forms, Medical Device Reporting, and Customer Letters. Reviewed prospective IDE data prior to FDA submission. Reviewed product manuals, communiqués and memorandums for technical/clinical accuracy and content.
Education
Master of Science - Biomedical Engineering
Case Western Reserve University
Cleveland, OhioBachelor of Science - Biomedical Engineering
Texas A&M University
College Station, TexasSkills
- FDA Class III PMA Supplements and Class II 510(k) submissions
- EU MDR Class I and Class III Initial Approvals and Change Notifications, including CE Mark and UK Mark
- Health Canada Class II, III, and III Licence Applications and Amendments
- Document & Engineering Change Orders, Supplier Quality & Supplier Change Notification, and Non-Conforming Material Report
Certification
- Regulatory Affairs Certification US 2016
- Regulatory Affairs Professional Society (RAPS)
COMPETENCIES
- FDA Class III PMA Supplements and Class II 510(k) submissions
- EU Medical Device Regulation (MDR) 2017/745
- Initial CE Mark MDR Approvals for Class I and Class III devices
- Health Canada Class II, III & IV License Applications and Amendments
- Document & Engineering Change Orders, Supplier Quality & Supplier Change Notification, and Non-Conforming Material Report
Timeline
Senior Regulatory Affairs Specialist, II
LeMaitre Vascular, Inc
09.2021 - Current
Senior Regulatory Affairs Specialist
Advanced Bionics, LLC
05.2017 - 09.2021
Regulatory Affairs Specialist (Contract)
Trigg Laboratories
01.2016 - 07.2016
Document Control (Contract)
Trigg Laboratories
08.2015 - 12.2015
Quality Systems Compliance Specialist
Zonare (acquired by Mindray)
12.2013 - 07.2015
Technical Support Engineer
Zonare (acquired by Mindray)
04.2012 - 12.2013
Technical Services Engineer I
St. Jude Medical Cardiac Rhythm Management Division
06.2010 - 03.2012
Technical Services Engineering Specialist
St. Jude Medical Cardiac Rhythm Management Division
10.2005 - 06.2010
Bachelor of Science - Biomedical Engineering
Texas A&M University
Master of Science - Biomedical Engineering
Case Western Reserve University