Responsibilities

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.

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 to for accuracy, comprehensiveness, and compliance with regulatory standards.

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 IVD products.

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

8. Support post-approval products through change evaluation and submission and annual reporting as required.

9. Set team objectives to ensure alignment with the business and regulatory strategies. 10. Other duties as assigned.

Qualifications

• Bachelor’s degree in science related field or equivalent required. Minimum 7 years of progressive experience in medical devices/IVD/biotech industry Regulatory Affairs required, including experience in Armed Forces. • RAC would be a plus • Experience working directly with regulatory agency representatives. • Thorough understanding of FDA, Health Canada regulations and requirements for in vitro diagnostic devices (21 CFR 820, Senior Manager, Regulatory Affairs ago Travel 10%

• Thorough understanding of the 510(k) process and working knowledge of CLSI guidelines requirements. • Hematology, Urinalysis, Flow Cytometry and Coagulation experience a plus. • PMP qualification would be a plus. • Medical Technology background preferred. • 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. • 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.