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 regulatory Pre-Submission documents for Next Generation Sequencing and / or PCR assays.
• Facilitate FDA pre-submission meetings.
• Prepare regulatory submissions (PMA, PMA supplement, and (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.
• Participate in business meetings with potential new external partners.

Requirements :