Find & Apply For Regulatory Affairs Manager Jobs in Lincolnshire, Illinois

Sr Manager, Regulatory Affairs & Quality Assurance - Surgical Robotics Sysmex America, Inc dental insurance, parental leave, paid time off, 401(k) United States, Illinois, Lincolnshire 577 West Aptakisic Road (Show on map) Sep 01, 2026 Sr Manager, Regulatory Affairs & Quality Assurance - Surgical Robotics

Job Location(s) US-IL-Lincolnshire # of Openings 1 Job

ID 2026-4804

Category Regulatory/Quality Travel 25% Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams.

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the Sysmex Way. ...to improve the lives of others. Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory. ...to build a promising future. Responsibilities We currently have a great opportunity for a Sr Manager, Regulatory Affairs & Quality Assurance - Surgical Robotics. The Senior Manager position in Regulatory Affairs and Quality Assurance leads the regulatory strategy for new and modified Surgical Robotics products. The individual will lead, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. The individual is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications. The individual may have the opportunity to manage team members and will report to the Sr. Director, Regulatory Affairs.

Essential Duties and Responsibilities:

1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes

2. Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA, Health Canada and other country-specific regulations as required.

3. Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards and set team objectives to ensure alignment with business and regulatory strategies.

4. Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.

5. Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced. Also ensuring adherence to internal procedures. Evaluate and implement continuous improvement in internal processes and procedures.

6. Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for medical devices products.

7. Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.

8. Support internal and external audits, including ISO and/or regulatory body audits.

9. Support the maintenance and continuous improvement of the quality management system to ensure ongoing compliance with applicable ISO standards and regulatory requirements.

10. Conduct post-market surveillance activities and support post-approval products through change evaluation and submission and annual reporting as required. Other duties as assigned.

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