Job Summary: Position is responsible for ensuring that domestic regulatory submissions are appropriately developed for approval and clearance of orthopedic products and their respective accessories. These Regulatory submissions can include, but are not limited to Premarket Approval Applications (PMAs) and Supplements, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and Premarket Notifications (510(k)s). Ensures regulatory interface throughout the product realization process and during the entire product life cycle including post-market surveillance.
Sit on design review teams and provide interactive feedback and assist in the development of supporting documentation.
Develop Regulatory strategy for projects.
Assist in the development and implementation of the post-market surveillance.
Develop documents to submit to FDA
Develop internal documentation when formal FDA submissions are not required (LTF or memo-to-file).
Review and approve marketing literature and other items for internal and external dissemination.
Review and approve all Engineering Change Requests (ECRs).
Assist in the development and updating of internal operating procedures.
Coordinate with International regulatory on submission timelines and the dissemination of information.
Liaise with clinical affairs and regulatory compliance departments to ensure appropriate reporting of adverse events for Class III products.
Develop progress reports and other misc. reports as needed.
Participate in special projects as needed.
Limited travel required (up 5%)
Performs related duties as required.
Job Specifications: Requires the ability to work with a variety of levels both within and outside the organization. Working knowledge of FDA and regulations and how to interpret and monitor them.
- Premarket notifications (510(k))
- Premarket Applications (PMA) – original or supplements
- Humanitarian Device Exemptions (HDE)
- The regulatory portion of an Investigational Device Exemption (IDE)
Skills And Abilities:
Knowledge of domestic/international medical device regulations
Strong attention to detail
Strong computer skills, including word
processing, spreadsheet and data programs
Good oral and written communication skills
Knowledge and skills identified are typically acquired by completing Bachelor’s or higher degree in clinical/science field, or similar work experience. Two to four years experience in device or pharmaceutical regulatory affairs is desired.
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