Senior Regulatory Affairs Manager

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Revvity

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10,000+

Description

• 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

Requirements

• Bachelors Degree in a life science related field • 8-10+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) • Travel as circumstances dictate • Excellent understanding of regulations and guidance documents required in Americas region • RAC certified • Excellent interpersonal, verbal and written communication skills (in English) • Excellent time management, organizational, negotiation, and problem- solving skills • Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management

Benefits

• Medical, Dental, and Vision Insurance Options • Life and Disability Insurance • Paid Time-Off • Parental Benefits • 401k with Company Match • Employee Stock Purchase Plan