Description
Regulatory Affairs Responsibilities;- European, US & International submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements.
- Submissions of new product to the US FDA via 510k route.
- Management of the relationship with a US based contract manufacturer for all quality and regulatory aspects, including the FDA compliance of the contract manufacturer.
- Review all product complaints & ensure timely reporting of those events to regulatory agencies as necessary.
- Represent Company with FDA, Notified Body & International regulatory agencies regarding Company's regulatory strategies & submissions; determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies;
Quality Responsibilities;
- Perform internal and external quality system audits as lead auditor, including establishing audit plans and writing audit reports. Schedule, ensure completion of, manage & respond to all audits including customer &/or supplier audits;
- Make decisions regarding all quality system related activities, and facilitate Quality Improvement Programs and work toward 100% "Right the First Time".
- Review & revise quality system documentations along with maintaining documentation on new equipment, inspections, and equipment repairs and failures.
- Ensure training of employees on Quality Systems Regulation & key International regulations & standards.
Required Experience;
- Bachelor of Science/Engineering with at least 5+ years' experience in the Regulatory/Clinical/Quality area or related experience with medical device.
- Strong experience with Bioresorbable polymers: PLLA and PLGA for the purpose of manufacturing requirements, quality and regulatory standards.
- Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical devices - thorough understanding of the MDD (Medical Device Directive).
- Previous direct interaction with the FDA & an EU Notified Body.
- Experience with US FDA submissions of new products, mostly via 510 k.
- Previous experience assuring that the Quality Systems function is carried out in accordance with GMP & ISO directives.
If you are looking for a new challenge and think you have the correct experience then please send me your CV and I will be in touch shortly, look forward to hearing from you.