🚀 Regulatory Affairs Manager

Responsibilities

• 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.
• 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.
• 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.
• Participate in business meetings with potential new external partners.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.

Requirements

• or equivalent experience in Biology, Chemistry, bioengineering, or related science at least years of IVD Regulatory Affairs experience.
• Hands-on experience with (k), PMA, and PMA supplement submissions.
• Knowledge of regulatory strategy creation, design control, cGMP / Quality Systems, and import / export requirements.
• Ability to lead multiple projects and meet deadlines.
• Strong communication and teamwork skills.
• Capacity to communicate regulations to technical functions within the company.
• Experience as the RA representative on project core teams.