Regulatory Affairs Manager

Responsibilities

• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
• Provide guidance to ensure that 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 the use of internal resources, regulatory agencies, and outside consultants as needed
• Document regulatory strategies for product submissions
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
• Serve as a liaison for 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 informed about 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

• B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science
• At least 5 years of IVD Regulatory Affairs experience
• Hands-on experience with 510(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
• Experience as the RA representative on project core teams