Principal, RA Specialist

About the role

At Integrated DNA Technologies (IDT), one of Danaher’s 15+ operating companies, our work saves lives. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. 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.

Responsibilities

• Develop and execute strategies for global market introduction of new and modified IVD medical devices and software
• 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, advise and approve 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 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
• Broad knowledge and previous application of ISO 13485, IVDR, and 21 CFR Part 820 required
• Experience in product development process inclusive of Design Control and Risk Management
• 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
• Previous experience in collaborating with international colleagues in global regions to submit application/registration documents

Qualifications

• Professional Experience
• Education
• Licensure, Certification, Registration

Skills

• Regulatory Affairs
• Product Development
• Collaboration
• Research and Analytical Skills

Benefits

At IDT, we offer 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 contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Pay

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

Schedule

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