This is a newly created position that has not existed in Chaska, MN.
The Director, Regulatory Affairs is primarily responsible for overseeing the creation and execution of regulatory strategies for pre-market activities, globally.
Provide oversite and direction regarding pre-market regulatory policy and practices for chemistry and immunoassay operations ensuring the development and implementation of advanced and pro-active regulatory strategies that provide a competitive advantage to Beckman Coulter.
Direct and facilitate teams of 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.
Work with management from all sites to facilitate and ensure company practices are consistent with the corporate regulatory risk posture, while also ensuring business teams consider the impact of current or emerging regulatory issues.
Ensure the timely and consistent review of post-market activities; such as adverse events and recall notification, minimizing the risk of negative pre-market submission actions, including agency review delays.
Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required.
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.
Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations.
Must be a collaborative facilitator and leader, building consensus while championing global regulatory initiatives.
Foster an environment that ensures the continued development of a high performing pre-market regulatory affairs team.
Collaborate across the organization at all levels, across functional groups and geographic locations - including executive management – in a complex matrix environment.
Preferred and Required Skills and Abilities
• Fifteen years of relevant experience in a regulated medical device/diagnostic industry is required.
• Ten years of supervisory and management experience is required.
• The proven ability to develop innovative regulatory strategies for products along the continuum from emerging research technology to routine IVD hardware, software and consumables is required.
• Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics is required.
• Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics is required.
• Experience in registration and commercialization of medical device and diagnostic products is required.
• The ability to develop effective regulatory strategies and apply regulations to pre-market strategies is required.
• A broad knowledge of surrounding areas professional medical device manufacturing areas, including Quality Assurance, Manufacturing and Development, is required.
• Proven leadership and managerial skills in order to build and sustain a vision for the work group, are required.
• Global experience leading and/or participating on cross functional teams is required.
• The proven ability to managing complex issues that may have significant impact on the business in a globally matrixed environment.
A Bachelor’s preferably in areas of life sciences, engineering, or quality assurance with 20+ years of experience is required.
A Master’s degree with 15+ years of experience is required.
An advanced scientific degree is strongly preferred.
Training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
This position is located in Chaska, MN and will required some travel. Relocation is available.
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: BEC014948
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.