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.
Responsibilities
Deliver regulatory guidance to project teams and external partners to achieve business goals.
Serve as the regulatory core team lead providing ongoing regulatory advice.
Ensure regulatory submissions are planned and executed according to requirements.
Document regulatory strategies for product submissions.
Facilitate U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays.
Prepare U.S. regulatory submissions (PMA, PMA supplement, 510(k)) for relevant assays.
Support creation of CE/IVD Technical Files for EU representatives.
Benefits
Collaborative work environment with a global regulatory team.
Opportunity to lead projects and make an impact on product development.
Chance to stay current with evolving regulations and industry standards.
Access to training and professional development resources.
Engagement with external partners and experts in the field.
Full Job Description
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 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.
ssist 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.
bility 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.
