Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
The Strategic Regulatory Affairs Manager is a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for premarket activities and managing complex issues that may have significant impact on the business. This individual contributor will manage global regulatory initiatives. The successful applicant will develop innovative regulatory strategies for products along the continuum from emerging research technology to routine IVD hardware, software and consumables
Must be a collaborative facilitator, building consensus while championing global regulatory initiatives for projects. Providing pre-market regulatory strategies for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge to Beckman Coulter.
Author premarket submissions, including 510(k)s and PMA’s to the U.S. FDA in alignment with pre-market strategies. Determine when pre-submission meetings are required with global agencies (including U.S. FDA and China FDA). Create Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market.
Collaborate with international Regulatory Affairs professionals to support global product registrations. Using knowledge of global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.
Ensure business teams consider the impact of current or emerging regulatory issues, works with Global Regulatory Affairs and other regulatory colleagues to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities; such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays.
Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required.
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals.
A Bachelor’s degree with 10-14 years of experience or Master’s degree with 12+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance. An advanced scientific degree is strongly preferred.
Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics
Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics.
Experience in registration and commercialization of medical device and diagnostic products.
Ability to develop effective regulatory strategies and apply regulations to premarket strategies.
Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.
Proven leadership and managerial skills in order to build and sustain a vision for the work group.
Demonstrated track record of developing organizational capability.
Global experience leading and/or participating on cross functional teams
Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
PERSONAL SKILLS / ATTRIBUTES:
Must possess excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex regulatory information to a wide variety of audiences and leveraging for the best outcome.
Critical thinker able to address complex situations and issues.
Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.
Acts decisively, holds position and challenges others appropriately.
Manage changing conditions, processes and approaches; lead organizations through change effectively.
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
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: BEC015919
About Beckman Coulter
We are proud to be a part of Danaher. 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.
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.
Beckman Co...ulter 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.