The Regulatory Affairs Supervisor will be responsible for the development, maintenance, and distribution of quality documents within the QMS ensuring compliance to relevant regulations, applying knowledge in the discipline of document management for the analysis and resolution of document management issues, including benchmarking against best practice and implementing innovative solutions.
- Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System - Management of the PMR system,Change Control Process and Documentation Control system for the QMS.
- Ensuring continuous compliance with the following: FDA Quality System Regulation 21 CFR 820 (QSR), Medical Device Directive, Health Canada Medical Device Regulations, ISO13485 Medical Device Quality Management System, ISO14971
- Provide advice on regulatory affairs requirements for all proposed changes to device design.
- Compilation of regulatory submissions: PMAs, CE Mark registration, 510(k) registration, Technical Dossiers and similar applications and notifications, annual reports, supplements and registrations.
- Leading the preparation and direct all activities for: FDA inspections, ISO 13485 surveillance audits, Corporate audits, Internal audits and Customer audits
- Customer complaint investigation, reporting, closure and trending.
- Review current technical product files for compliance to international requirements.
- Answer all customer regulatory requests and complaints.
- Act as regulatory affairs representative on product design and R&D redevelopment teams.
- Design and implementing quality systems improvements.
- Support plant validation documentation programs as required, ensuring records are maintained.
- Degree or equivalent combination of education and experience
- 3+ years configuration management/document control experience.
- 3+ years of prior supervisory or management experience.
- Competent in preparing written communication and correspondence.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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