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About the Role

The Principal Regulatory Affairs Specialist will develop and execute strategies for global market introduction of new and modified IVD medical devices and software. This role acts as a Subject Matter Expert within the Global Regulatory team and provides mentorship to associates.

Responsibilities

• Author and lead the creation of regulatory documents (submissions/filings, registration and listing, technical files) to obtain global approvals.
• Collaborate with international colleagues to submit application/registration documents.
• Provide guidance and approve regulatory/quality documentation for new product development.
• Act as a core team member conducting regulatory assessments related to design changes.
• Advise on and approve protocols, reports, and marketing material.
• Assess risk levels associated with current and emerging regulatory issues.
• Provide guidance to 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.

Requirements

• Bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related.
• Minimum 7 years of experience in a regulated environment.
• Minimum 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.
• 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.

Skills

• Global regulatory affairs
• IVD regulations
• PMA submissions
• De novo submissions
• 510(k) submissions
• Technical file preparation
• Product development process
• Design Control
• Risk Management
• ISO 13485
• IVDR
• 21 CFR Part 820
• Research skills
• Analytical skills
• Project management

Location

• Boulder, CO

Work Type

• Fully remote

Experience Level

• Principal
• Minimum 7 years of experience
• 4+ years of global regulatory experience

Education Level

• Bachelor's degree in a technical field

Salary/Compensations

• $110,000 - $135,000

Benefits

• Paid time off
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)

About the Company

• Integrated DNA Technologies (IDT) is one of Danaher’s operating companies.
• IDT's work saves lives within life sciences, diagnostics, and biotechnology.
• The company is committed to innovation for tangible impact.
• IDT fosters a culture of belonging where unique viewpoints matter.
• IDT utilizes Danaher's system of continuous improvement to turn ideas into impact.
• The team at IDT is united by a commitment to collaboration and scientific excellence.
• IDT has a strong foundation of innovation, expertise, and reliability.
• IDT's vision is to help researchers rapidly move from the lab to life-changing advances.
• IDT works closely with global partners to accelerate progress and genomics breakthroughs.
• IDT is part of a culture rooted in continuous learning and improvement.
• IDT's mission is to accelerate the pace of genomics and help shape a healthier, brighter future.
• Learn about the Danaher Business System which makes everything possible.
• Danaher Corporation and all Danaher Companies are committed to equal opportunity.
• For more information, visit www.danaher.com.

Equal Opportunity

• Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
• The U.S. EEO posters are available here.
• We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.