Senior Manager, Regulatory Affairs

Job Location(s) US-IL-Lincolnshire
Posted Date 4 months ago(12/11/2023 1:46 PM)
# of Openings
1
Job ID
2023-3713
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 Senior Manager. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medical device products. The individual will lead, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Sr Manager Regulatory Affairs will have the opportunity to manage RA 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 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.

 

Percentage of Travel: Minimal 5-10%

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, ISO 13485, ISO 14971, CMDR).
• 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.

 

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 the individual’s ability to provide proof of current vaccination status.  Sysmex makes reasonable accommodations when needed for medical or religious reasons.  However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.

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.

 

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