Danaher Corporation Staff Regulatory Affairs in Chicago, Illinois
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 position is with the Immunoassay Regulatory Affairs team and reports to the Regulatory Affairs Manager; it will be either hybrid in Chaska, MN or Remote.
This role is responsible for managing global regulatory initiatives, working with third parties as appropriate. The Staff RA role will build consensus while championing global regulatory initiatives for projects. They will also provide pre-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge to Beckman Coulter. 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.
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.
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
Expertise with FDA interactions and working with international regulations for medical devices
Working knowledge of the product development process and design controls
Prior experience developing effective pre-market regulatory strategies
Prior experience with regulatory submission, such as 510(k)s, IVDR or MDRs, PMA supplements
Works independently, with guidance in only the most complex situations
This is also a plus:
Knowledge and understanding of regulations and guidelines governing in-vitro diagnostics
International experience with products in China or Europe
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.
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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.