- A minimum of a BA/BS in a scientific related field
- A minimum of 3 years’ experience of medical device industry
- Regulatory affairs experience
- Quality System experience (FDA, ISO, etc.)
- Risk Management experience
- IDEs through to PMAs
- Assessment of risks related to regulatory and development activities
- Computer literate; use of word processing, spreadsheets
- Perform change order reviews
- Completes PCNs (product change notices)
- Support day to day regulatory activities
- Gate keeps regulatory policies and procedures to assure compliance with FDA and international Quality System requirements.
- Monitor and continuously improve regulatory process and product compliance.
- Review quality and product documentation (DCR’s, labeling, etc.) to ensure compliance with global regulatory agencies
- Record and complete incoming registration/re-registration documentation requests from the IDM and the FDA, research each request and send documentation as appropriate
- Maintain technical files, design dossiers and all regulatory documentation in compliance with the Medical Device Directive and the Code of Federal Regulations.
- Assure all regulatory documentation being sent to IDM and/or FDA is accurate and in compliance with regulatory requirements and Company procedures.
- Communicate with all Company departments as needed to fulfill job requirements
- May research, monitor or prepare semi-routine reports or analyses, summarize findings and make recommendations to solve administrative problems
- Adheres to all environmental, health and safety SOP’s, policies and procedures, including any department specific requirements, Good Manufacturing Practices, 21CFR Part 820
Source: Job Diva – Job Listing