We are looking for a Quality Assurance and Regulatory Affairs Manager to join a mid-size medical device company in Verona, Virginia. The ideal candidate will have a strong regulatory background and knowledge of international regulations and submissions, as well as strong experience with FDA Audits.
Responsibilities:
- Developing and implementing quality management systems
- Ensuring compliance with international regulations and submissions
- Preparing and managing regulatory submissions, including 510(k) applications, PMA supplements, and CE Marking
- Conducting internal audits and supplier audits
- Managing the CAPA system
- Leading FDA inspections and responding to FDA observations
- Providing regulatory guidance to cross-functional teams
- Developing and delivering training on quality and regulatory topics
Skills:
- 7+ years of experience in the Medical Device industry
- Knowledge of international regulations and submissions
- Strong experience with FDA Audits
- Experience managing/implementing quality management systems
- Experience conducting internal audits and supplier audits
- Strong communication skills
- Ability to work in a fast-paced environment
