Responsible for 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:
- 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.
- B.S. degree in a scientific discipline (i.e. Biology, Biochemistry, or Chemistry)
- 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.
- 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
Thermo Fisher Scientific - 23 months ago
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