Senior Regulatory Affairs Manager

Job not on LinkedIn

October 15

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

+3 more states

🐊 Florida – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote ⚔️ Virginia – Remote

💵 $140k - $150k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Revvity

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Revvity is a science-based solutions company that leverages innovation across life sciences and diagnostics to improve lives everywhere. The company serves a diverse customer base, including academia, pharma/biotech, clinical laboratories, and healthcare professionals. Its extensive range of products and services includes genomic analysis, clinical diagnostics, cell and gene therapy, drug discovery, precision medicine, and advanced automation solutions. Revvity is committed to empowering scientists with cutting-edge tools and comprehensive solutions to enhance research and development, diagnostics, and clinical testing. With a focus on accelerating time to market while ensuring quality, Revvity is dedicated to revolutionizing next-generation breakthroughs in healthcare and life sciences.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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

• Bachelor's Degree in a STEM field • 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field • 4+ 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 • Compassionate Care Leave • 401k with Company Match • Employee Stock Purchase Plan