Beckman Coulter Diagnostics
Staff Regulatory Affairs
Beckman Coulter Diagnostics, Chicago, Illinois, United States, 60290
Overview
Beckman Coulter Diagnostics, a Danaher operating company, is hiring for the Staff Regulatory Affairs role. 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. Responsibilities
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, work 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. Qualifications
The essential requirements: 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 Compensation, Benefits and Work Arrangement
The annual salary range for this role is $130k to $180k annually. This role is eligible for a remote work arrangement and may be eligible for bonus/incentive pay. Beckman Coulter Diagnostics offers comprehensive benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. The company is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, or gender identity or other characteristics protected by law. For more information, visit www.danaher.com.
#J-18808-Ljbffr
Beckman Coulter Diagnostics, a Danaher operating company, is hiring for the Staff Regulatory Affairs role. 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. Responsibilities
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, work 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. Qualifications
The essential requirements: 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 Compensation, Benefits and Work Arrangement
The annual salary range for this role is $130k to $180k annually. This role is eligible for a remote work arrangement and may be eligible for bonus/incentive pay. Beckman Coulter Diagnostics offers comprehensive benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. The company is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, or gender identity or other characteristics protected by law. For more information, visit www.danaher.com.
#J-18808-Ljbffr