Sr Manager, Regulatory Affairs & Quality Assurance – Surgical Robotics

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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. Find a better way: 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.

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.

Travel Percentage: <25%

Physical Risk: No unusual exposures to risk.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

• Bachelor’s degree in science related field or equivalent experience required. Minimum 7+ years of progressive experience in medical device industry Regulatory Affairs required.

• RAC would be a plus

• Experience working directly with regulatory agency representatives.
• Thorough understanding of FDA, Health Canada regulations and requirements for medical devices (21 CFR 820, ISO 13485, ISO 14971, CMDR).
• Thorough understanding of the 510(k) process and Canada MDL application process requirements.
• Working knowledge of medical device standards, such as IEC 62304, IEC 60601, IEC 62366, ISO 14155 and applicable usability, software, cybersecurity, and labeling expectations.
• Prior Surgical robotics experience a plus.
• PMP qualification would be a plus.
• English
• Japanese would be a plus
• Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe etc.
• Ability to follow guidelines and effectively communicate scientific data in a structured manner.
• Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary to support product applications or submissions.
• Motivated individual with hands-on RA/QA experience, excellent communication skills, ability to communicate and work at all levels or the organization.
• Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.
• Ability to lead & work as part of a team.

The salary range for this role is $126,000-$175,000. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.