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Danaher Corporation Staff Regulatory Affairs, NPD in Minneapolis, Minnesota

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!

The Staff Regulatory Affairs, New Product Development for Beckman Diagnostics will report to the Vice President, Quality Regulatory Affairs/Clinical Decision Support System. This role will be a individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre-market activities and managing complex issues that may have significant impact on the business.

This position is in the Clinical Decision Support Solutions (CDS) business unit, part of the Global Regulatory Affairs team. The role will be fully remote or may work hybrid in one of Beckman Coulter’s facilities.

This individual is accountable for leading global regulatory initiatives, working with third parties as appropriate. They will build consensus while championing global regulatory initiatives for projects and drive pre-market regulatory initiatives to ensure the development and implementation of sophisticated and aggressive regulatory strategies to give Beckman Coulter a driven competitive edge.

If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on!

In this role, you will have the opportunity to:

  • Author global pre-market submissions, including 510(k) and De Novo to the U.S. FDA in alignment with pre-market and post-market strategies.

  • Translate regulatory policies and requirements into strategies.

  • Participate in execution of CDS devices and digital health products involving use of SaMD, Artificial Intelligence, and Machine Learning to achieve clearances/approvals in alignment with business priorities.

  • Collaborate with cross functional project teams to develop and execute regulatory strategy for devices and resolve action items and deliverables needed for market clearance.

  • Prepare the vital documentation and secure approvals and respond to regulatory agency inquiries.

  • Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements and provide regulatory oversight in support of design changes.

  • Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate.

  • Ensure company practices are consistent with the corporate regulatory risk posture.

  • Assure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

  • Create and manage Technical Files in compliance with IVDR and work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.

  • Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market company’s products in that geography.

  • Apply and/or write complete the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.

The essential requirements of the job include:

  • Bachelor's Degree in life sciences, engineering, computer science or related field and 9 years of relevant experience or Masters’ degree with 7 years of experience or Doctoral with 4 years of experience

  • Subject matter expertise in registration and commercialization of medical devices, including 510(k) and De Novo to the FDA

  • Demonstrated experience developing effective pre-market regulatory strategies

  • Experience with medical device development process, design changes and design controls; establishing and implementing premarket regulatory strategy and good knowledge of software development lifecycle

  • Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies

  • Works well independently and is pragmatic with strong problem-solving skills

  • Experience working with cross-functional product development teams to ensure regulatory compliance

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

  • Experience with SaMD, AI/ML, mobile app, and consumer facing health solutions

  • Clinical study design and software device performance evaluation

  • Advanced degree in life sciences, engineering, or a related field

  • RAC certificate

  • PMA experience

  • International experience with products in China or Europe

  • FDA audits in multiple roles (regulatory representative, back-room lead, scribe, etc.) and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources

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Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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