|Sr. Regulatory Affairs Specialist (Medical Device)|
San Francisco | Bay Area | California
Our client, a global pharmaceutical company is looking for a Sr. Regulatory Specialist to join their IVD product facility as a key member of an award-winning team.
The incumbent will be responsible for the preparation of regulatory submissions required to market new or modified in-vitro diagnostic devices in both domestic and international markets including all relevant maintenance activities.
Minimum Requirements and Qualifications:
- Serve as core member of Regulatory IVD, Diagnostics team
- Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, and technical files for CE marking.
- Prepares and/or compiles information required by ex-U.S. regulatory associates to support registration or licensing products outside the U.S.
- Interacts with applicable regulatory bodies.
- Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.
- Interacts with R&D and other cross functional departments to ensure proper coordination of information to meet regulatory requirements.
- Reviews and approves change orders.
- Acts independently to determine and coordinate methods and procedures on new assignments.
- B.S. degree in a scientific discipline (i.e. Biology, Biochemistry, or Chemistry) from a credited university
- Minimum of 5-8 years related experience and/or training or equivalent combination of education and experience in diagnostics or medical device.
- Current knowledge of FDA QSR 21 CFR 820, U.S. medical device and in vitro diagnostic regulatory requirements, IVD Directive requirements and ISO standards.
- Post market experience preferred, 13485 experience preferred