Olympus America Inc. Evergreen Regulatory Affairs Analyst - External in San Jose, California
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The Regulatory Affairs Analyst will be responsible for the review and investigation of medical device complaints. The incumbent will coordinate the resolution of complaints and ensures that timely investigations are performed. He/She will prepare and file Medical Device Report (MDR) for Medical Systems Group (MSG) products. The incumbent will maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility. He/She will function as part of MSG's Regulatory Affairs team, in fulfillment of corporate objectives for FDA regulatory compliance. The incumbent will require general instruction for routine assignments, from Supervisor and or more experienced staff. He/She must communicate with Sales or Marketing team and other internal or external customers to investigate occurrences related to adverse events and provide information. EOE M/F/D/V
Primary Hiring Locations: San Jose, CA
Review and perform RA investigation for medical device complaints, and determines the resolution of the complaint with general direction from supervisor and or more experienced staff.
Determine if further inquiries are required with field resources (ESS, TT, Sales Rep or customer).
Perform follow up inquiry and documents all communications in compliance with MSG good documentation practices and department procedures with general direction from supervisor and or more experienced staff.
Determine if a reported event classifies as a Medical Device Reportable as defined by various regulatory agency.
File proper documentation with applicable agencies as required.
Prepare and submit MDRs Supplemental reports for review to Supervisor in a timely manner.
Ensure work performed is accurate and complete.
Coordinate MDR investigations with Infection Control staff.
Monitor and track progress of any outside laboratory evaluation, when necessary.
May interface with FDA and other regulatory agencies regarding complaints.
Maintain traceability, and manually and electronically document the applicable elements of the complaint handling process, such as contact records with the external customers, database update, and complaint closure letters Improves the complaint handling process for better efficiency and greater integrity.
Enter complaint and investigation related information in the database.
Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Gyrus ACMI at http://www.gyrusacmi.com/
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor's degree in scientific discipline or equivalent is required.
Minimum of 3 years of complaint handling experience in a closely related field in the medical device and or pharmaceutical industry or equivalent is required.
Gyrus ACMI at http://www.gyrusacmi.com/
Evergreen Requisition - Regulatory Affairs Analyst
Reg Affairs/Quality Assurance
California, San Jose
San Jose OCA
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