- This position requires a Bachelor degree in Engineering or related field and a minimum of 1 year experience developing, implementing, and maintaining regulatory systems in the medical device industry.
- Basic understanding of FDA regulations, ISO 13485: 2003, ISO 14971: 2007, Medical Device Directive (93/42/EEC), and other national and international regulations and standards
- Possess strong customer and supplier interface skills and experience with regulatory agency inspections, compliance audits, and international requirements.
- RAC certification through the Regulatory Affairs Professional Society is a plus.
- This position will have responsibility to develop, implement, and coordinate quality and regulatory compliance programs for Transdermal Cap, Inc.
- This position will lead the efforts to ensure compliance with internal company policies and procedures for the organization, as well as international quality system standards (e.g., ISO 13485, ISO 14971) and regulations (e.g., 21 CFR 820) and will assist in management of the relationship with the third party notified body.
- Will serve as a secondary interface to the FDA and international regulatory agencies.
- Provide subject matter expertise pertaining to the implementation of regulatory requirements for the manufacturing of medical devices.
- Represent the company during FDA discussions and actively participate and analyze regulatory correspondence and coordinates follow-up discussion with internal colleagues and external parties to ensure all regulatory request and commitments are met with accuracy and in a timely fashion.
Indeed - 18 months ago
Small Medical Device Manufacturer of Low level laser devices to treat hair loss in men and women. Based out of Lakewood, Ohio