Principal, RA Specialist

Danaher Corporation; United States; Remote; USD 110.000 - 135.000; Vollzeit

Benefits dieser Stelle

Remote work option

Zusammenfassung

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Principal Regulatory Affairs Specialist to develop and execute global regulatory strategies for IVD medical devices and software, and to mentor entry-level staff.

You will author regulatory submissions, lead registrations, assess regulatory risk, and collaborate with cross-functional teams to ensure compliance with FDA, EU IVDR, ISO 13485, and 21 CFR Part 820 standards.

Qualifikationen

• Bachelor's degree in chemistry, biology, or related field.
• 7+ years in regulated environments; 4+ years global regulatory in IVD.
• Experience with FDA and EU IVD regulations; PMA/De Novo/510(k) submissions.

Aufgaben

• Author and lead regulatory submissions and registrations to obtain global approvals.
• Provide guidance on regulatory/quality documentation for product development.
• Assess regulatory risks and ensure compliance with standards and SOPs.

Kenntnisse

Regulatory submissions

Global regulatory

FDA/IVD regs

Design Control

Risk Management

ISO 13485/IVDR

Ausbildung

Bachelor's degree in technical field

Jobbeschreibung

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 of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanaher’s 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, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.

Learn about the Danaher Business System which makes everything possible.

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.

The essential requirements of the job include:

Education, Licensure, Certification, Registration

• Bachelor’s 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 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.

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

IDT,a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contributedto life beyond the job. Check out our benefits at Danaher 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 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 forIDT can provide.

The annual salary range for this role is $110,000-$135,000. 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.

This job is also eligible for bonus/incentive pay.

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

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion until paid and may be modified at the Company’s sole discretion, consistent with the law.

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For more information, visit www.danaher.com.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].