Senior Regulatory Affairs Manager- REMOTE

Revvity

4d•$140 - $150•Remote

About The Position

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 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 Please note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding.

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)

Nice To Haves

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

Responsibilities

Supports 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.