Director, Regulatory Affairs
: Job Details :

Director, Regulatory AffairsJob Location(s)US-IL-Lincolnshire# of Openings1Job ID2024-4162CategoryRegulatory/QualityTravel25%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. 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.

Responsibilities

We currently have a great opportunity available for a Regulatory Affairs Director. The Director position in Regulatory Affairs is focused on directing and developing the regulatory strategy for new and modified Sysmex medical device products. The individual will lead regulatory development, submission strategies, and interface with relevant regulatory authorities. The Director will be a regulatory subject matter expert on medical devices and In-Vitro Diagnostics. The position will be responsible for directing the activities of regulatory affairs associates, including hiring and mentoring Regulatory Affairs Associates and ensuring accurate and timely product submissions for Sysmex.

Essential Duties and Responsibilities:

1. Responsible for developing & implementing the strategy, preparation, documentation and submission of FDA applications and provide responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance.2. Oversee review of regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.3. Provide regulatory leadership to departments or development project teams regarding design, development, evaluation, or marketing of products.4. Leads team members in implementing regulatory affairs procedures to sustain or enhance regulatory compliance. Also ensuring adherence to internal procedures.5. Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for IVD products. 6. Support project teams through development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes. 7. Ensure understanding of risk and approximate timing for approvals for planning purposes.8. Support post-approval products through change evaluation and submission and annual reporting as required. 9. Provide input on appropriate clinical study protocols to accurately assessment of IVD products.10. Other duties as assigned.

Percentage of Travel: 5-10%

Qualifications

Bachelor's degree in science related field or equivalent required. Minimum 10+ years of progressive experience in in vitro diagnostics, medical devices, biotechnology or Laboratory Medical Technology, including experience in Armed Forces. Advanced degree preferred.
• RAC desired
• Experience working directly with regulatory agency representatives.
• Thorough understanding of FDA, Health Canada regulations and requirements for in vitro diagnostic devices (21 CFR 820, ISO 13485, ISO 14971, IEC 62304, CMDR).
• Thorough understanding of the 510(k) process and working knowledge of CLSI guidelines requirements.
• Demonstrated successful interactions with regulatory bodies, specifically related to medical device & IVD submissions (Q-Sub, 510(k), Health Canada, CE Mark and amendments/supplements).
• Hematology, Urinalysis, Flow Cytometry, Coagulation or related IVD software experience a plus.
• PMP qualification desired.
• Medical Technology background preferred.
• English
• Japanese desired
• Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe etc.
• Excellent communication, collaboration & interpersonal skills. Ability to communicate and work at all levels or the organization
• Ability to follow guidelines and effectively communicate scientific data in a structured manner. Understands and interprets scientific data related to regulatory requirements and strategy and provides knowledge and expertise to guide others.
• Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary to support product applications or submissions.
• Strong organizational skills and high attention to detail.
• Ability to influence others & create a positive working environment.
• Ability to lead & work as part of a team.

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.