Senior Regulatory Affairs Manager- REMOTE

Senior Regulatory Affairs ManagerLocation(s) :US Remote - CT, US Remote - FL, US Remote - GA, US Remote - MA, US Remote - NC, US Remote - NJ, US Remote - VARevvity 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 11,000colleagues 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 RevvitySupports North America regulatory activitiesEnsure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needsEnsure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirementsDevelop North America regulatory strategies plan for submission for IVD productsAssess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessmentSupport global regulatory teams and / or in-country dealers / representatives with regulatory registrations of IVD productsMaintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the businessProvide input and feedback on clinical study protocols to ensure regulatory requirements are incorporatedSupport CE marking activities for IVD products and other market clearance for products manufactured globallyReview and approve promotional materials and product labelingSupport importation / exportation permitting activitiesBasic Qualifications :Bachelor's Degree in a STEM field6years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)ORMaster's or PhD degree in a STEM field4years 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 dictateExcellent understanding of regulations and guidance documents required in the Americas regionRAC certifiedExcellent interpersonal, verbal and written communication skills (in English)Excellent time management, organizational, negotiation, and problem-solving skillsAbility to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of managementCompensation range :The annual base salary range for this full-time position is $140-150,000.This range reflects the minimum and maximum target for a new hire in this position.The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training.Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Please note that base pay is only one part of our total compensation package and is determined within a range.This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company.This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.We provide competitive and comprehensive benefits to our employees.Below are some highlights of our benefits :Medical, Dental, and Vision Insurance OptionsLife and Disability InsurancePaid Time-OffParental BenefitsCompassionate Care Leave401k with Company MatchEmployee Stock Purchase PlanRevvity is an equal opportunity employer.All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and / or local laws.If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the abilityor unable to usethe online application system and need an alternative method for applying, you may contact [email protected].. Experience: 5 years required