Regulatory Affairs Manager

Responsibilities

• 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.