Description
An in-vitro diagnostics company in Fremont, CA is looking to add a regulatory affairs senior specialist to their team to help with 510(K) clearances and regulatory intelligence. There will be room for growth within the team and there will be a high level of autonomy for the regulatory affairs senior specialist.Major Responsibilities:
- Acts as a core member on development teams to provide regulatory guidance, and develop regulatory strategies and timelines
- 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, pre-IDE, 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
Desired Skills and Experience
- B.S. degree in a scientific discipline (i.e. Biology, Biochemistry, or Chemistry) from a credited university
- 510(K) authorship experience
- Minimum of 5-8 years related experience and/or training or equivalent combination of education and experience in diagnostics or medical device
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations
- Ability to compile data and summarize results
- Post market experience preferred, 13485 experience preferred