The Senior Manager of Regulatory Affairs develops, designs, manages and integrates Beckman Coulter’s regulatory strategies and programs. As a regulatory process expert to development teams and the regulatory department, the incumbent creates and integrates advanced regulatory strategies for global registrations and compliance activities; provides regulatory leadership in promotional material review, experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees to develop harmonized policies, procedures and work instructions for emerging regulatory topics. This position will manage a team of 7-10 employees supporting new product development and product sustainment activities for global registrations, assessment of design changes, and support of IVDR compliance initiatives.
Build and develop a high performing regulatory affairs team.
Support staff in managing workload within assigned projects through efficient resource utilization
Provide strategic direction for new product development regulatory strategies aimed at improving time to market globally.
Oversee and ensure efficient processes for global registrations and post market compliance.
Prepare necessary documentation (e.g. Pre-Submissions, 510(k), STEDs, CDRH Laser Reports) and secure necessary clearance and country approvals. Respond to regulatory agency inquiries.
Work to interpret federal/state/international regulations as they apply to our products, processes and/or procedures, advise on impact of regulations, and devise strategies to compliance.
Liaison with external regulatory agencies. Determine the need for and prepare regulatory submissions (e.g. Pre-Submissions, 510(k), STEDs), negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
Participate in the development and/or review of Health Authority policy, guidance, regulations.
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.
Oversee program and staff to ensure readiness for EU IVDR compliance.
Manage and maintain WHO pre-qualified products
Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
Collaborate across the organization at all levels, across business units, functional groups and geographic locations, including executive management.
Utilize Danaher Business System (DBS) tools to drive compliant and effective processes; improve capability to support market growth
Bachelor’s degree in areas of Science, Regulatory Affairs, or Engineering; advanced degree preferred.
Professional designations are not required but training and relevant certifications would be a plus (e.g. RAC, CLIA, ASQ Certified Biomedical Auditor or Manager of Quality/Organizational Excellence)
15 years’ experience in a regulated medical device/diagnostic industry (fewer years’ required with advanced degree)
10 years’ supervisory and management experience
Experience working with cross-functional product development teams to ensure regulatory compliance.
Demonstrated successful experience negotiating complex premarket and post market regulatory strategies with FDA, CFDA and other regulatory agencies
Experience in writing and submitting premarket submissions, including but not limited to pre-submission and 510(k), to regulatory agencies.
Experience preparing submissions documents for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
Experience applying 21 CFR 803, 806 and 820 regulations. Experience with FDA UDI compliance.
Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.
Experience with ISO 13485, ISO 14971, ISO 18113, ISO 15223, ISO 13612 and European IVD Directive and IVDR.
Experience with product life cycle regulations, including experience with change controls, design controls, risk management, clinical study, and verification and validation activities.
Experience supporting and streamlining international regulatory activities. Experience with applying and/or writing the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity. Experience with legalization, Apostille, and notarization process.
Diversity & Inclusion
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.
Internal Number: BEC015393
About Beckman Coulter Miami
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
We are proud to be a Danaher company. Beckman Coulter offers 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 think you'll like what you see.
If you belie...ve your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.