The Regulatory Affairs Specialist IV is a staff-level individual contributor and subject-matter expert who will interpret federal/state/international regulations as they apply to our products, processes and/or procedures, advise on impact of regulations, and devise strategies for compliance.
Collaborate with Program Managers and technical staff to determine action items and deliverables.
Track and report status of regulatory deliverables to Program Managers and leadership.
Liaison with external regulatory agencies.
Determine 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.
Ensure company complies with the local regulatory requirements of the country in which the product is marketed.
Prepare the necessary documentation, and secure necessary approvals.
Respond to regulatory agency inquiries.
Apply and/or write the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.
Manage legalization, Apostille, and notarization process.
Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
Bachelor's degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 5 years of experience in the offered position or related
OR Master’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 years of experience in the offered position or related
Authoring of at least 1 (one) USA FDA 510(K) Submission required.
SPECIAL SKILLS AND EXPERIENCE REQUIREMENTS:
Successful candidate must have authored at least one (1) 510K.
Establishing and implementing premarket regulatory strategy.
Writing and submitting premarket submissions to regulatory agencies. Experience
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 and responding to agency inquiries.
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.
IVDR experience is a plus.
Excellent organizational skills and attention to detail.
Strong work ethic with an ability to work independently.
Possess an ability to read, understand, and summarize technical and scientific information.
Ability to interpret and apply regulations to company policies and procedures. Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling.
Pragmatic with strong problem-solving skills.
Experience working with cross-functional product development teams to ensure regulatory compliance.
Internal Number: R1103654
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.