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Job Type:
Not Specified

Industry: Regulatory/Quality

Company: Sysmex

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 Sr. Regulatory Affairs Specialist to work on Cybersecurity related regulations. The Sr RA Specialist is responsible for supporting compliance to FDA and Canada regulations, listings and licenses. The individual will also collaborate with regulatory affairs to develop, implement, and maintain software and cybersecurity framework and procedures to maintain and ensure compliance with medical device regulatory requirements. The individual will coordinate and collect specific product registration, listing and licensing information and support submission of regulatory documents to FDA and other appropriate regulatory agencies according to requirements, including software and cybersecurity. The individual will also support product labeling and advertising/promotional material review and approval activities and other regulatory tasks as needed. The Sr. Regulatory Affairs Specialist will report to the Sr. Director of Regulatory Affairs.

Essential Duties and Responsibilities:

1. Assist management in the development, implementation, and maintaince of software and cybersecurity framework and procedures to maintain and ensure compliance with medical device regulatory requirements.
2. Coordinate, compile, and maintain U.S, and/or International regulatory facility registrations, product listings/licenses and other country-specific product registrations.
3. Maintain device establishment registrations, listings and licensing renewals and maintenance activities for compliance with FDA and other country-specific regulations as required.
4. Support regulatory affaris in software and cybersecurity submission activities for new products and/or product changes to gain required clearance/approval for market release through the appropriate premarket approval process.
5. Support the review of product labeling, promotional material, change control and other related product documentation.
6. Collaborate with regulatory on surveillance of all pertinent software and cybersecurity medical device regulations to ensure submission requirements are current, up-to-date and ensures information of such regulations and requirements, particularly those that are new or modified, are distributed to appropriate personnel.
7. Assist with regulatory audits from partners and external regulatory agencies.
8. Assists with development and maintenance of regulatory affairs product files and standard operating procedures for compliance with applicable regulations, with a focus on software and cybersecurity.
9. Prepare and submit Certificates to Foreign government/Export application requests to FDA in support of regulatory submissions for Sysmex affiliates.
10. Other duties as assigned.

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 (computer science, information technology, engineering or similar) is required plus a minimum of 5 years’ experience working in an IVD or medical device manufacturing environment or regulatory affairs.
  • General knowledge of:
    • 21 CFR 820, ISO 13485 – Quality System Regulation and design controls
    • FDA, Health Canada regulations on in vitro diagnostic devices and software/cybersecurity
    • Understanding of industry best practices and cybersecurity concepts
    • Software development lifecycle, risk management (IEC 62304, ISO 14971)
  • English
  • Japanese a plus
  • Excellent general IT skills ie Microsoft Office/Outlook etc some Adobe skills required.
  • Must be able adaptable to handle multiple tasks and execute deliverables to timeline commitments.
  • Strong organizational skills and high attention to detail.
  • Must be comfortable in a fast-paced. high-profile environment.
  • Ability to work effectively as a team member.
  • Excellent communication skills, ability to communicate and work at all levels or the organization.
  • Ability to write clear, understandable technical documentation.

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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