JENNIFER RAPSAVAGE
Warsaw,IN
Summary
Hardworking Associate Director with extensive knowledge and experience in Medical Device Post Market regulations. Direct leadership of global complaint handling for a large medical device company.
Overview
19
19
years of professional experience
Work History
Associate Director Product Surveillance
Zimmer Biomet
12.2021 - Current
- Global subject matter expert for complaint handling, regulatory reporting and all global procedures.
- Communicates effectively with global competent authorities.
- Front room audit lead.
- Prioritized tasks and allocated resources appropriately to keep teams focused and productive.
- Leads a large team of 75 individual contributors and 6 managers.
- Collaborates with departments to ensure product performance and safety issues are addressed.
- Review proposed regulatory changes and evaluated potential impacts on business operations.
- Budget management
Manager Product Surveillance
Zimmer Biomet
10.2018 - 12.2021
- Responsible for leading the complaint handling team in day to day management in compliance with regulations and procedures
- This includes providing guidance on regulations and workload management
- Efficiently manage and motivate a team of 13 Complaint Specialists
- Daily/weekly and Monthly metrics monitoring to ensure expected goals and KPIs are being achieved
- Monitor monthly complaint audits to identify compliance trends
- Assist with internal and external audits with backroom and front room support
- CAPA owner
- Effectively execute other site integrations into our local complaint handling
- Author or review Corporate and Site level procedures
- Assist with constructing and approving responses due to the regulatory bodies.
Associate Manager Product Surveillance
Zimmer Biomet
07.2017 - 10.2018
- Responsible for leading the complaint handling team in day to day management in compliance with regulations and procedures
- This includes providing guidance on regulations and workload management
- Approve regulatory reports sent to the Competent Authorities
- Approve not reportable decision trees
- CAPA owner
- Write and update corporate procedures and work instructions
- Train and manage contract employees assisting with remediation
- Department Subject Matter Expert
- Ensure department is meeting all requirements for Corporate procedures and Government Regulations while processing complaints in a timely manner.
Regulatory Compliance/Post Market Surveillance
Zimmer Biomet
07.2008 - 07.2017
- Product Surveillance Senior Coordinator-Zimmer
- Strong Contributor to the Interim Control Process for Post Market Surveillance
- Key player in the ETQ Reliance implementation process for the Warsaw site
- CAPA Owner
- Approve Regulatory Reports submitted to the FDA and Competent Authorities
- Process new complaints; this includes approving Medwatch reports, writing Medwatch and Vigilance Reports while meeting all regulations of the FDA
- Ensure the complaint file is complete and accurate per Procedures and Regulations
- Daily communication with many levels of management regarding the disposition of product complaints
- Conduct training and oversea contract employee helping with backlog
- Department Subject Matter Expert
- Review surgical reports
- Weekly Complaint Reports and Audits
- Handled all instrument recall administration.
Server
NOA NOA
01.2005 - 01.2011
- This position offers the enjoyment of serving and interacting with various members of the community.
Safety and Benefits Administrator
SPARTECH PLASTICS
01.2007 - 10.2007
- Job functions included enrolling and administering health, vision, dental and life insurance policies for employees
- Administered Short Term and Long Term Disability and FMLA
- Maintained worker’s compensation and the OSHA 300 log
- Served as a member of the safety committee and assisted the company’s plant manager.
Clerk
POST MARKET SURVEILLANCE (Kelly Services)
09.2006 - 01.2007
- Assisted the Product Surveillance Engineers, Technicians and Coordinator; maintained the excel spreadsheet with information regarding all new complaints along with closing the complaint with Development’s written response
- Responsible for entering all of the worn instrument data, photographed all complaint product returned to Warsaw
- Assisted with the implementation of Pilgrim.
Education
Bachelor of Science - Business Administration
Indiana Tech
Ft Wayne, InCertified BSI ISO13485 Auditor
Skills
- Project Management
- Budget Development
- Process Improvement
- Verbal and Written Communication
- Strategic Leadership
- Excellent working knowledge of FDA Regulations 21 CRF Part 803, 806 and 820
- Excellent regulatory reporting knowledge of European Medical Device Directives and Canadian Medical Device Regulations
- Experience with numerous complaint handling software; ETQ, Pilgrim and Enovia
- CAPA administration
Timeline
Associate Director Product Surveillance
Zimmer Biomet
12.2021 - Current
Manager Product Surveillance
Zimmer Biomet
10.2018 - 12.2021
Associate Manager Product Surveillance
Zimmer Biomet
07.2017 - 10.2018
Regulatory Compliance/Post Market Surveillance
Zimmer Biomet
07.2008 - 07.2017
Safety and Benefits Administrator
SPARTECH PLASTICS
01.2007 - 10.2007
Clerk
POST MARKET SURVEILLANCE (Kelly Services)
09.2006 - 01.2007
Server
NOA NOA
01.2005 - 01.2011
Bachelor of Science - Business Administration
Indiana Tech
Certified BSI ISO13485 Auditor
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