Illinois Staffing
Regulatory Affairs Staff
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The Staff Regulatory Affairs is responsible for high-level strategies and subject-matter expertise, responsible for creating and executing regulatory strategies for pre-market activities and managing complex issues that may have a significant impact on the business. This position reports to the Senior Regulatory Affairs Manager and is part of the Immunoassay Regulatory Affairs team located in Chaska and will be fully remote. In this role, you will have the opportunity to: Author and manage global pre-market submissions, including 510(k)s, PMAs and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies. Collaborate with cross functional project teams to develop and execute regulatory strategy for new product development and resolve action items and deliverables needed for market clearances. Create and manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes. Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture. Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays. The essential requirements of the job include: Must possess a bachelor's degree with 9+ years of experience or a master's degree with 7+ years of experience or a Doctorate Degree with 4+ years of experience, preferably in engineering or software-related discipline. Long-standing experience in IVD industry. Education preferably in the engineering or software-related disciplines. Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA. IVDR experience Immunoassay product Development expertise. This is also a plus: Knowledge and understanding of regulations and guidelines governing in-vitro diagnostics RAC certificate PMA experience International experience with products in China or Europe Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. The annual salary range for this role is $130k to $180k, annually. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The Staff Regulatory Affairs is responsible for high-level strategies and subject-matter expertise, responsible for creating and executing regulatory strategies for pre-market activities and managing complex issues that may have a significant impact on the business. This position reports to the Senior Regulatory Affairs Manager and is part of the Immunoassay Regulatory Affairs team located in Chaska and will be fully remote. In this role, you will have the opportunity to: Author and manage global pre-market submissions, including 510(k)s, PMAs and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies. Collaborate with cross functional project teams to develop and execute regulatory strategy for new product development and resolve action items and deliverables needed for market clearances. Create and manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes. Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture. Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays. The essential requirements of the job include: Must possess a bachelor's degree with 9+ years of experience or a master's degree with 7+ years of experience or a Doctorate Degree with 4+ years of experience, preferably in engineering or software-related discipline. Long-standing experience in IVD industry. Education preferably in the engineering or software-related disciplines. Subject matter expertise in registration and commercialization of medical devices, including 510(k) to the FDA. IVDR experience Immunoassay product Development expertise. This is also a plus: Knowledge and understanding of regulations and guidelines governing in-vitro diagnostics RAC certificate PMA experience International experience with products in China or Europe Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. The annual salary range for this role is $130k to $180k, annually. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.