Regulatory Affairs Manager

Regulatory Affairs Specialist

Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.

The 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.

Serve as the regulatory core team lead and provide active and 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 their creation of CE/IVD Technical Files

Support global regulatory registration representatives for product registration activities

Perform regulatory assessment of new and changed products.

Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.

Conduct training and/or communicate appropriate materials, as needed, 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.