Sysmex Manager, Project in Mundelein, Illinois
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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.
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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 a Regulatory Affairs Project Manager. The Regulatory Affairs Project Manager will combine knowledge of scientific, regulatory and business issues to enable assigned project to progress while meeting required legislation. The manager executes and manages technical & scientific regulatory activities and must assure that deadlines are met. Effectively communicate, prepare and negotiate both internally and externally. Properly interpret and apply regulatory requirements. The individual may identify data needed for the assigned projects, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Essential Duties and Responsibilities:
Knowledge of regulations and standards affecting Sysmex Inostics business. Comply with all polices, established procedures, and regulations. Maintains professional, product and market expertise via internal training as well as independent reading, networking and training.
Participate assigned projects, monitor regulatory outcomes of initial project/ product concepts and provide input to senior regulatory management. Monitor the progress of all assigned projects and assures adherence to intended timelines and data/ report deliverables. Identify issues that may impact the overall project plan and initiate contingency plans as appropriate.
Provides a timely review of technical data, labeling, promotional material, and product documents. Implements the approval process for new products and product changes to assure timely market entry.
Prepare assigned regulatory filings including CE technical files & other international documents and handle subsequent team interactions related to amendments, periodic report requirements for ongoing applications and any additional compliance reporting to global regulatory authorities on behalf of Sysmex Inostics.
Assist in the development of multi-country regulatory project needs and provide updates based upon regulatory changes.
Develop, review and advise on regulatory compliance for promotional, advertising and labeling to prevent off-label promotion/ advertising and other non-compliant activities. Develop/ improve, implement and manage appropriate standard operating procedures to track and manage regulatory compliance activities and train key personnel on them.
Keep abreast of newly published standards and regulations (especially in the area of Companion Diagnostics), and provide regulatory awareness & updates.
Manage and prepare pre-approval compliance activities. Ensure compliance with CLIA and all other IVD applicable requirements.
Ensure that product safety issues and product-associated events are properly communicated among internal stakeholders before reporting to regulatory agencies.
Liaise cross functionally with R&D;, Laboratory Operations, Quality, Project Management, Marketing and Commercial Operations.
- Excellent communication skills, ability to communicate and work at all levels or the organization.
- Excellent general IT skills i.e. 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 as part of a team.
- 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.
- 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. Required Experience
Bachelor’s degree in science related field or equivalent and A minimum of 5 years of progressive experience in Regulatory Affairs.
- Previous experience in Medical Technology preferred.
- Experience working directly with regulatory agency representatives.
- Hematology, urinalysis and coagulation experience a plus.
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.
Tracking Code: 940-458
Job Location: Mundelein, Illinois, United States
Position Type: Full-Time/Regular