Staff Regulatory Affairs Specialist
We are growing! Beckman Coulter is introducing 118 new or improved products in 3 years!
If you thrive in a multifunctional, collaborative, fast-paced role and want to work to continue to build a world-class organization—read on!
The Staff Regulatory Affairs position requires a subject-matter expert who will work on new products, new applications, and global strategies using your regulatory and design controls experience. You’ll apply your experience interpreting federal/state/international regulations as they apply to our products, processes and/or procedures, advise on impact of regulations, and devise strategies for compliance.
Is this what you like to do?
We support the Hematology, Urinalysis, and Flow Cytometry business units to develop, lead, and integrate Beckman Coulter’s regulatory strategies and programs.
- Collaborate with Program Managers and technical staff cross functional project teams to provide regulatory strategy for devices and resolve action items and deliverables needed for market clearance.
- Establish the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
- 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.
- Prepare the vital documentation and secure approvals.
- Respond to regulatory agency inquiries.
- Apply and/or write complete the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.
- Lead legalization, Apostille, and notarization process.
- Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
- Provide regulatory oversight in support of design changes.
- Other duties as required at the Staff level.
Apply now if you have these qualifications
- Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 9 years of experience in the offered position or related; OR Master’s degree with same plus 7 years of experience in same OR Doctoral degree or foreign equivalent) in same plus 4 years of experience in same
- Successful candidate must have authored at least one (1) 510K.
- Experience with medical device development process, design changes and design controls; establishing and implementing premarket regulatory strategy; writing and submitting premarket submissions to regulatory agencies; preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
- Applying 21 CFR 803, 806 and 820 regulations.
- Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies.
- 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.
- Strong work ethic and can work independently. Pragmatic with strong problem-solving skills.
- Experience working with cross-functional product development teams to ensure regulatory compliance.
- Knowledge of EU IVDR regulations is a plus, not required.
We offer a broad array of comprehensive, competitive benefit programs that add value to associates’ and their families’ lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We believe you’ll like what you see.
Beckman Coulter is a Danaher Operating Company. As a $20B company with 60,000 associates, ranked #162 on the Fortune 500 and, during the past 25 years, DHR stock has outperformed the S&P 500 Index by more than 2,000 percent. The strength of our results is a testament to our teams and the power of the Danaher Business System. Our Purpose: “Helping Realize Life’s Potential” is what makes us excited to come to work each day.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or email firstname.lastname@example.org 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.
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Job posted: 2020-12-15