Regulatory Affairs Manager

Job TitleThe delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.Responsibilities include:Serving as the regulatory core team lead and providing active and ongoing regulatory guidance to project teamsProviding guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirementsDocumenting regulatory strategies for product submissionsFacilitating and preparing U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assaysFacilitating FDA pre-submission meetingsPreparing U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assaysSupporting EU representatives in their creation of CE/IVD Technical FilesSupporting global regulatory registration representatives for product registration activitiesPerforming regulatory assessment of new and changed productsStaying on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.Conducting training and/or communicating appropriate materials, as needed, to improve the team's knowledge of working in a regulated environmentParticipating in business meetings with potential new external partnersAssisting the Regulatory department in updating, improving, and crafting internal policies and proceduresRequirements include:B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experienceHands-on experience with 510(k), PMA, and PMA supplement submissionsKnowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirementsAbility to lead multiple projects and meet deadlinesStrong communication and teamwork skillsCapacity to communicate regulations to technical functions within the companyExperience as the RA representative on project core teams