Manager, Regulatory Affairs and Quality Assurance - LATAM
Sysmex America, Inc.
May 17, 2018
Full Time - Experienced
Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
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 a Regulatory Affairs and Quality AssuranceManager. The Manager position in Regulatory and Quality Assurance contributes to the regulatory strategy in the LATAM Affiliates (Region 2) 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.
For the QA function, the Manager is responsible for maintenance of the Quality and Health and Safety Systems, following each countries GMP requirements.
Essential Duties and Responsibilities:
Responsible for the preparation, documentation and submission of COFEPRIS, INVIMA and ANMAT applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance, review of device labeling, labeling changes to ensure compliance with regulatory requirements.
Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards. Liaise with regulatory partners in managing and controlling regulatory and technical source documentation.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products and ensure regulatory affairs rules and procedures to make sure that regulatory compliance is sustained or enhanced. Also ensuring adherence to internal procedures.
Maintain registrations for existing devices including evaluating changes to existing devices to ensure continued compliance with regulatory requirements. Coordinate with regulatory colleagues to obtain Certificates of Free Sale (CFS) and Certificates to Foreign Government CFG).
Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for IVD products.
Support post-approval products through change evaluation and submission and annual reporting as required.
Execute Quality System functions related to Post Market Vigilance within each country, such as MDR reporting, management of complaints, issuance of FCAs.
Establish process for controlled records, and a Document Management System within each country.
Train Sysmex Associates within each country on Quality System procedures.
Oversee Quality System functions within Affiliate offices of each country, as well as Distributors supporting the Sysmex business.
Physical Risk: Regular exposures to risk that may require special training and precautions.
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.
Bachelor's Degree in science related field, or equivalent and 8 years of progressive experience in Regulatory Affairs and Quality Systems required.
Medical Technology background preferred.
Experience working directly with regulatory agency representatives
Thorough understanding of US CFR, Mexico COFEPRIS, Columbia INVIMA and Argentina ANMAT regulations and requirements for in vitro diagnostic devices.
Good foundation in laboratory testing methodologies.
Effective verbal and written communication skills in Spanish, English and potentially other LATAM languages (Brazilian Portuguese)
Excellent organizational and managerial skills
Computer literacy to operate standard word processing, spreadsheets, presentation and internet application.
Detail oriented with strong prioritization skills.
Ability to travel up to 40% of time.
Laboratory &/or LIS computer skills would be a plus.
Effective project and time management skills.
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.