Senior Regulatory Affairs Manager- REMOTE

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity 

• 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

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Basic Qualifications:

• Bachelor's Degree in a STEM field
• 12+ 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
• 10+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)

Preferred Qualifications:

• ​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

What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options

• Life and Disability Insurance  

• Paid Time-Off

• Parental Benefits

• 401k with Company Match

• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Why Revvity page.

*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.

Revvity is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. Revvity is committed to a culturally diverse workforce.