Principal, RA Specialist

Danaher•Boulder, CO

1d•Remote

About The Position

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. In this role, you will have the opportunity to: 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.

Requirements

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

Nice To Haves

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.

Responsibilities

Develop and execute strategies for global market introduction of new and modified IVD medical devices and software.
Act as a SME within the Global Regulatory team.
Provide mentorship to entry-level and intermediate associates.
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.
Collaborate with international colleagues in global regions to submit application/registration documents.
Provide guidance and approve regulatory/quality documentation related to new product development deliverables.
Conduct regulatory assessments related to design changes as a core team member.
Advise on and approve protocols, reports, and marketing material.
Assess risk levels associated with current and emerging regulatory issues.
Provide guidance to facilitate and ensure practices are consistent with 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.