at Sysmex America, Inc in Lincolnshire, Illinois, United States
Job Description
Manager, Regulatory Affairs
Job Location(s)
US-IL-Lincolnshire
# of Openings
1
Job ID
2024-3922
Category
Regulatory/Quality
Travel
10%
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 Manager. The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The individual will need to identify, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products.
Essential Duties and Responsibilities:
1. Prepare, write and document submissions for FDA and Health Canada applications. Responds to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance.
2. Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards.
3. Core team member on project teams, providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
4. Develop submission regulatory strategies and plans and provide guidance regarding regulatory requirements for device changes.
5. Maintain regulatory affairs procedures to ensure regulatory compliance is sustained or enhanced as well as ensuring adherence to internal procedures.
6. Maintain current knowledge of relevant regulations and guidelines including proposed and final rules for IVD products.
7. Appy understanding of Design Controls, Risk management, Quality systems relating to risk and submission timing.
8. Support post-approval products through change evaluation and submission and annual reporting as required.
9. Review analytical and clinical study protocols for related IVD products.
10. Other duties, as required.
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.
Percentage of Travel: Minimal 5-10%
Qualifications
Bachelor's degree in science related field or equivalent required. Minimum 5+ years of progressive experience in medical devices/IVD/biotech industry Regulatory Affairs required, including experience in Armed Forces.
Medical Technology background or RAC qualification would be a plus.
Experience working directly with regulatory agency representatives.
Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices.
Thorough understanding of the 510(k) process and working knowledge of CLSI guidelines requirements.
Hematology, Urinalysis, Flow Cytometry and Coagulation experience a plus.
English
Japanese would be a plus
Excellent general IT skills i.e. Microsoft Office/Outlook etc.
Ability to follow guidelines and effectively communicate scientific data in a clear manner.
Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary support for product applications or submissions.
Excellent communication skills, ability to communicate and work at all levels of the organization.
Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.
Ability to work as part of a team.
Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon... For full info follow application link.
