Regulatory Affairs Manager

Responsibilities Provide guidance to ensure all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. Serve as a subject matter expert on various regulations, coordinating regulatory issue resolution through internal resources, regulatory agencies, and outside consultants as needed. Deliver regulatory guidance to project teams and external partners to assist the company in achieving its business goals. Serve as a member of the Global Regulatory department. Lead the regulatory core team and provide active, ongoing regulatory guidance to project teams. Document regulatory strategies for product submissions. Facilitate and prepare U.S. regulatory pre‑submission documents for next‑generation sequencing and/or PCR assays. Facilitate FDA pre‑submission meetings. Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for next‑generation sequencing and/or PCR assays. Support EU representatives in creating CE/IVD technical files. Support global regulatory registration representatives for product registration activities. Perform regulatory assessment of new and changed products. Stay current on new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials to improve the team's knowledge of working in a regulated environment. Assist the Regulatory department in updating, improving, and crafting internal policies and procedures. Requirements B.Sc. or equivalent experience in biology, chemistry, bioengineering, or related science. At least 4+ years of IVD regulatory affairs experience. Hands‑on experience with 510(k), PMA, and PMA supplement submissions. Deep knowledge of regulatory strategy creation, design control, cGMP/quality systems, and import/export requirements. Experience as the RA representative on project core teams. Strong communication and teamwork skills. Ability to lead multiple projects and meet deadlines. Capacity to communicate regulations to technical functions within the company. #J-18808-Ljbffr