Description
Essential Responsibilities:- Responsible for all worldwide regulatory submissions including FDA 510K, annual reports, and all amendments, etc. for all regulatory bodies
- Supports the ongoing compliance by identifying and correcting gaps in procedures as required and designing and presenting training programs to educate employees
- Ensure ISO 13485 compliance
- Prepare and manage 510(k) submissions
- Ensure compliance with the various worldwide standards
- Coordinate product registration process in foreign countries
- Leads Corrective and Preventive Action (CAPA) activities and uses Root Causes Analysis tools to document CAPA activities
- Responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints
- Supports AMD product development process, document and implement regulatory strategies, including registration requirements, needed to help facilitate timely launch of new products
Desired Skills and Experience:
- Thorough understanding of FDA Quality System regulation, ISO 13485, ISO 14971, MDD (93/42/EEC)
- 5-10 years experience with Medical Device Quality and Regulatory Affairs with US and European regulations. Knowledge of other international regulations including Canada, Japan, China, and Australia is desired
- Bachelors Degree in technical discipline, preferably life sciences
- Minimum 5 years experience in Regulatory Affairs for a Pharmaceutical, Biotech, or Medical Device company
- Class II Medical Device Manufacturing experience is preferred
- Project Management experience
- Previous domestic/international submissions experience
- Regulatory Affairs Certification (RAC) is preferred
Demonstrated experience with:
- FDA 510(k) submission process
- 21 CFR part 820 and 1040
- Hands-on approach to projects, good attitude and work ethics
- Ability to work in a flexible and small entrepreneurial environment