Clintel Services, Inc. Regulatory Affairs Specialist (Medical Devices) in Santa Clarita, California
A medical device company is actively seeking a Regulatory Affairs Specialist to join their company in the Santa Clarita, CA area.
Position will be managing complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues.
- BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline
- 5+ years of experience in the medical device industry
- preferably in a small manufacturing/R&D environment
- experience with medical writing, clinical studies, regulatory submissions, and regulatory reviews
- Must have experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
- Ability to independently analyze and interpret novel clinical, medical and scientific data
- Current knowledge of current U.S. FDA and global (Canada, Australia, European Union, Latin America, India, China, etc.) regulatory requirements within the medical device industry.
- Excellent organizational skills and attention to detail
- Strong analytical, management, communication and interpersonal skills. Good knowledge of MS Office, Internet, databases, etc.
- Ability to work with minimal supervision in a busy environment
- Excellent writing skills and the ability to write scientific summaries
- Must be able to handle multiple assignments and perform in a diverse cross-functional team environment