The Sr. Regulatory Affairs Specialist serves as the lead regulatory representative on Paragon 28 product and project teams supporting product lifecycle management activities. Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies.
- Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware
- Maintain expert knowledge of appropriate regulations, legislation,…
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