Sr. Director, Regulatory Affairs

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. 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 available for a Regulatory Affairs Sr. Director. The Sr Director of Regulatory leads the organization in developing the Americas regulatory strategy for Robot Assisted Surgical (RAS) system, instruments, and accessories for minimally invasive surgical procedures. This individual will collaborate with our partners at Medicaroid Japan along with the SAI Clinical and Quality teams to bring RAS medical devices to market through the Americas Clinical and regulatory framework while ensuring compliance of the quality system.

Essential Duties and Responsibilities:

1. Identify, assess, and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities.
2. Responsible for directing the preparation, documentation and submission of regulatory applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance.
3. Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards.
4. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
5. Support project teams through development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
6. Maintain current knowledge of relevant regulations and guidelines, both proposed and final rules.
7. Ensure understanding of risk and approximate timing for approvals for planning purposes.
8. Support post-market products through change evaluation and submission and annual reporting as required.
9. Provide input on appropriate pre-clinical, usability, and clinical study protocols to accurately assess the safety and efficacy of RAS products, instruments, and accessories.
10. Other duties as assigned

Percentage of Travel: Ability to travel up to 25%, domestic and international.

Physical Risk: Regular exposures to risk that may require special training and precautions.

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 with 15 years of experience preferably in medical devices, surgical devices or surgical environment including Sr. management experience. Master's degree preferred. Robot Assisted Surgical Devices experience preferred.
• RAPs certification a Plus
• Strong working knowledge of FDA Regulations around 21 CFR 876.1500, ICH Guidelines and GCPs governing the conduct of clinical trials.
• Proficient in Microsoft Office
• Strong written and verbal communication skills
• Resourceful and ability to take initiative in a fast-paced, dynamic organization.

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.