KH
Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Manager or above
- 9 months ago
- PCR
9 months ago
Not enough detail in this posting to match
- 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 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.
- 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.
- Capacity to communicate regulations to technical functions within the company.
- Experience as the RA representative on project core teams.
Regulatory Affairs Manager · Katalyst Healthcares & Life Sciences