Staff Regulatory Affairs

Danaher • Chaska, MN

115d • $130,000 - $180,000 • Remote

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, 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. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

Requirements

• Must possess a bachelor's degree with 9+ years of experience or a master's degree with 7+ years of experience or a Doctorate Degree with 4+ years of experience, preferably in engineering or software-related discipline.
• Long-standing experience in IVD industry.
• Education preferably in the engineering or software-related disciplines.
• Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA.
• IVDR experience.
• Immunoassay product Development expertise.

Nice To Haves

• Knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
• RAC certificate.
• PMA experience.
• International experience with products in China or Europe.

Responsibilities

• Author and manage global pre-market submissions, including 510(k)s, PMAs and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies.
• Collaborate with cross functional project teams to develop and execute regulatory strategy for new product development and resolve action items and deliverables needed for market clearances.
• Create and manage Technical Files in compliance with IVDD and IVDR.
• Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
• Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
• Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

Benefits

• Comprehensive, competitive benefit programs including paid time off, medical/dental/vision insurance, and 401(k).
• Flexible, remote working arrangements for eligible roles.
• Bonus/incentive pay.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree