Principal, RA Specialist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

AtIntegrated DNA Technologies (IDT)one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Our team at Integrated DNA Technologies (IDT) is united by a commitment to collaboration and scientific excellence building on a strong foundation of innovation expertise and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer infectious disease rare genetic disorders and more. At IDT youll be part of a culture rooted in continuous learning and improvementwhere your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier brighter future for all.

Learn about theDanaher Business Systemwhich makes everything possible.

ThePrincipal Regulatory Affairs Specialistis responsiblefor 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 positionreports to theManager Regulatory Affairsandis part of theRegulatory Affairs teamlocated inBoulder COand will befully 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 andSOPs; interpret new and/or existing regulatory requirements ensuring compliance with applicable agency requirements published standards local procedures and project specific plans.

The essential requirements of the job include:

Education Licensure Certification Registration

• Bachelors degree in a technical field such as chemistry biochemistry biology or related

Professional Experience:

• Minimum 7 years of experience in regulated environment required; 4 years of global regulatory experience related toin vitro diagnosticsrequired.

• 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.

It would be a plus if you also possess previous experience in:

• 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

IDTa Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.

AtIDTwe believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working forIDTcan provide.

Theannualsalary range for this role is$110000-$135000.This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.