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Position Overview The Sr Regulatory Affairs Manager is responsible for supporting the development and operations team’s compliance with FDA, CLIA, CAP, IVDR, and other global regulatory requirements. This position will be responsible for working cross-functionally to support key regulatory submissions as well as interfacing with regulatory authorities and key business partners. Key Responsibilities and Essential Functions (Oversees or Manages) regulatory filings for new product introductions, and expanded indications, including providing guidance for requirements and authorizing/reviewing regulatory filing documentation Oversees/Manages submissions in multiple ex-US jurisdictions, including the EU, APAC, Australia, an