Revvity · 3 hours ago

Senior Regulatory Affairs Manager- REMOTE

Boston, MA

Full-time

Remote

Senior Level, Lead/Staff

12+ years exp

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Responsibilities

Oversee North America Regulatory activities

Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs

Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements,

Develop North America regulatory strategies plan for submission for IVD products

Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment

Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products

Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business

Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated

Support CE marking activities for IVD products and other market clearance for products manufactured globally

Review and approve promotional materials and product labeling

Support importation/exportation permitting activities

Qualification

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Regulatory AffairsIVD RegulationsRAC CertificationTechnical File SubmissionsLife Science DegreeUS 510(k)PMADE NoVo