Job Summary
A company that manufactures and sells device-based medical therapies is in need of a Remote Principal Regulatory Affairs Specialist in Santa Rosa.
Core Responsibilities Include:
- Teaming with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support
- Preparing FDA submissions for new products and product changes as required
- Providing support to currently-marketed products as necessary
Must meet the following requirements for consideration:
- Bachelor’s degree
- Minimum 7 years experience in regulatory affairs or the medical device industry, OR advanced degree and a minimum of 5 years of experience in regulatory affairs, or the medical device industry.
- Experience working with medical device or pharmaceutical regulatory submissions
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
