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.

• 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.