The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Quality/Risk Management, Regulatory Compliance, Research & Development, Worldwide Regulatory Affairs
4 Year Degree
As the Senior Product Safety Compliance Engineer, you will directly impact worldwide product placement. In this role, you will primarily support current marketed product lines.
In this capacity, you will participate at a Client Testing Facility for an OSHA accredited National Testing Laboratory (NRTL). You will be certified by CSA Group and other NRTLs to perform all product safety testing on their behalf and directly support faster time to market of new products.
Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
Investigates and resolves compliance problems, questions and complaints.
Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.
Executes appropriately on product recalls.
Respond to regulatory agency inquiries.
Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
Educational and Experience Requirements
Bachelor’s degree in Engineering, Technology, Science or similar and 5+ years of experience OR Master’s degree and 3+ years of experience.
Electronics circuit evaluation and troubleshooting and interpretation of schematic diagrams.
Experience in conducting hands-on testing on mechanical and electrical systems with regards to product safety, and to interpret results.
Collaboration with electrical designers.
Ability to write complex technical test reports.
Must have proven problem solving, analytical and logical reasoning skills.
Additional Salary Information: 5% annual bonus potential, major medical and 401K begin Day 1 of employment
Internal Number: R1100495
About Beckman Coulter, Inc.
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.