Job Description

Job Description

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 for Beckman Coulter Diagnostics team is responsible for supporting new product development initiatives, working with third parties as appropriate. In this role, the Staff Regulatory Affairs Specialist will develop global regulatory strategies for research use only products to develop in vitro diagnostic uses and follow required regulatory pathways to clearance and/or approval. They will provide pre-market regulatory initiatives to ensure the development and implementation of advanced and aggressive regulatory strategies, providing creative solutions for products that gives a competitive edge to Beckman Coulter. 

You will be a part of the Regulatory Affairs team and will be in a Remote position. At Beckman coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

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 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 for novel intended uses.
• Create and manage Technical Files in compliance with 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.

The essential requirements of the job include:

• Bachelor's Degree with 9+ years of experience in Life Sciences or Master's Degree with 7+ Years of experience in Life Sciences or Doctorate with 4+ years of experience in Life Sciences
• Demonstrated depth and expertise in FDA and international regulations for medical devices
• Advanced understanding of the product development process and design controls
• Prior experience developing effective pre-market regulatory strategies
• Experience with regulatory submission including 510(k)s, IVDR or technical documentation

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

• Proven effectiveness working with complex product development strategies
• Knowledge and understanding of regulations and guidelines governing in-vitro diagnostics
• PMA or De Novo experience

#LI-MR1
#LI-Remote

At Beckman Coulter Diagnostics we 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 a 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 for Beckman Coulter Diagnostics can provide.

The salary range for this role is $125K-145K. 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. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay. 

We offer a 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 unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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.

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.

Job Tags

Remote job, Flexible hours,

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