Principal, RA Specialist

About the role

The Principal Regulatory Affairs Specialist is responsible for developing and executing strategies for global market introduction of new and modified IVD medical devices and software while acting as a SME within the Global Regulatory team and providing mentorship to entry-level and intermediate associates. This position reports to the Manager, Regulatory Affairs and is part of the Regulatory Affairs team located in Boulder, CO and will be fully remote.

Responsibilities

• Author and lead the creation of regulatory documents (regulatory submissions/filings, registration and listing, technical files, etc.) to obtain global approvals to commercially distribute products; collaborates with international colleagues in global regions to submit application/registration documents.
• Provide guidance and approve regulatory/quality documentation related to new product development deliverables acting as core team member conducting regulatory assessments related to design changes, advising and approving protocols, reports, marketing material, etc.
• Assess risk levels associated with current and emerging regulatory issues, providing guidance to facilitate and ensure practices are consistent with the corporate guidance and SOPs; interpret new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans.

Qualifications

• Bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related
• Minimum 7 years of experience in regulated environment required; 4+ years of global regulatory experience related to in vitro diagnostics required
• Knowledge and experience in U.S. FDA and EU IVD regulations; with proven experience in submission of PMA, de novo, 510(k) and/or technical files required
• Experience and understanding of product development process inclusive of Design Control and Risk Management; broad knowledge and previous application of ISO 13485, IVDR, and 21 CFR Part 820 required

Preferred skills

• Strong collaborative facilitation skills with the ability to build consensus while championing global regulatory compliance
• Ability to work independently utilizing developed research and analytical skills to manage multiple projects
• Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance

Pay

The annual salary range for this role is $110,000 - $135,000. This job is also eligible for bonus/incentive pay.

Benefits

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Schedule

This position is eligible for a remote work arrangement in which you can work remotely from your home.