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Senior Analyst, Regulatory Affairs - Remote Considered
Sturtevant, WI
Job Description
Wondering what's within Beckman Coulter?
Take a closer look.
Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Have the opportunity to build a meaningful career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible.
We hope you'll see yourself here, too. What you find at Beckman Coulter - and within yourself - might just change the world!
The Senior Analyst Regulatory Affairs for Beckman Coulter Diagnostics is an individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre-market and post-market activities. Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations. Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.
This position is in the Immunoassay Regulatory Affairs team and reports to the Manager of Regulatory Affairs in Chaska, MN or Remote location will be considered. This role is responsible for managing regulatory initiatives and working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. 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 global pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies.
* 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.
* Function as the team expert for promotional material review, experimental design review, data analysis and product labeling as they relate to product registration and commercialization of IVD medical devices.
The essential requirements of the job include
* Bachelor's Degree with 5+ years of experience in Life Sciences or a Master's Degree with 3+ Years of experience in Life Sciences or Doctorate with 0-2 years of experience in Life Sciences
* Subject matter expertise in registration and commercialization of medical devices
* Demonstrated experience developing effective pre-market regulatory strategies
This is also a plus:
* Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
* RAC certificate
* Strong FDA, Health Canada, and EU submission experience
Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates' lives. Whether it's a health care program or paid time off, our programs add to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. We believe you'll like what you see!
At Beckman Coulter, we're driven by a sense of wonder for what we can create-and what we can become. As part of the Danaher's 67,000 associates across the globe, your possibilities for growth and development are unparalleled.
We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that's why we're taking concrete steps to ensure that we're fostering an inclusive and engaging workplace for our team. If you'd like to learn more, read about our associates on our Careers Blog or contact one of our recruiters.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.
Job Summary
Company
Danaher
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
5+ years
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