We are searching for a Regulatory Affairs Manager for a highly regarded medical devices company in San Diego. The Regulatory Affairs Manager will create, review, maintain and update regulatory files for all regulated and non-regulated products, ensuring proper documentation for U.S. and international distribution.
Requirements for the Regulatory Affairs Manager:
- Bachelor’s degree, preferably in life sciences, engineering or a technical discipline
- 7+ years progressive experience in medical device regulatory affairs.
- 5+ years in a leadership role
- Strong leadership skills with a track record of developing and mentoring teams to their highest potential.
- Proven experience creating, reviewing and submitting technical documentation to national and international agencies for product approvals.
- Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred
- A “can do” mindset, results oriented, performance management.
- Strong communications skills; oral, written, and electronic. The ability to connect at all levels within an organization, from subordinates to executive.
- Strong attention to detail, with a track record of accomplishment in managing multiple competing priorities. Energetic and motivated personality, with excellent time management skills.
Occupational Category: 11-9199.01 Regulatory Affairs Managers
: Please apply using the form or send your resume to Debbie Winkelbauer