Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Lincolnshire, Illinois
SPECIALIST, REGULATORY AFFAIRS
Job Location(s) US-IL-Lincolnshire
Posted Date 5 hours ago(1/9/2019 2:07 PM)
# of Openings
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 an Regulatory Affairs Specialist. The Regulatory Affairs Specialist is responsible for supporting compliance to FDA, Canada and Latin America regulations, listings and licenses and applicable international regulations. The individual will coordinate, compile, and submit regulatory documents to FDA and other appropriate regulatory agencies according to requirements. The individual will provide support for all regulatory compliance activities including change control impact assessment, product labeling and promotional material review, import and export activities and other regulatory tasks as needed. The Regulatory Affairs Specialist will report to the Sr. Manager of Regulatory Affairs.
Essential Duties and Responsibilities:
* Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
* Maintain device establishments, device listings and device licensing renewal and maintenance activities for compliance with FDA and other country-specific regulations.
* In collaboration with regulatory management, support submission activities for new products and/or product changes to gain required clearance/approval for market release through the appropriate premarket approval process.
* Provide guidance and review of product labeling, promotional material, change control and other related product documentation.
* Conducts ongoing surveillance of all pertinent domestic and international 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.
* Assist with regulatory audits from partners and external regulatory agencies
* Assists with development and maintenance of regulatory affairs product files and standard operating procedures for compliance with applicable regulations.
* Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.
* May participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are met prior to commercial release.
* Prepare and submit Certificates to Foreign government/Export application requests to FDA in support of regulatory submissions for Sysmex affiliates. Other duties, as needed.
Physical Risk: No unusual exposures to risk.
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%
* Minimum Bachelor s Degree in science related field, or equivalent. Medical Technology background preferred.
* A minimum of 4 years previous experience in Regulatory Affairs.
* Thorough understanding of FDA regulations and requirements for in vitro diagnostic devices and working knowledge of CLSI guidelines requirements.
Excellent communication skills, ability to communicate and work at all levels or the organization. * Excellent general IT skills ie Microsoft Office/Outlook etc.
Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.
Ability to work effectively as a team member.
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 sex, sexual orientation, gender identity, color, religion, national origin, disability, protected Veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing..