Olympus America Inc. Evergreen Regulatory Affairs Specialist - External in Southborough, Massachusetts
Perform internal quality audits per the OSTA Corporate Internal Audit Program.
Plan, conduct, and report internal audits as scheduled in accordance with part 820, ISO 13485 and other relevant regulations and standards.
Follow up resolution of internal audit findings and external audit findings through the OSTA Corrective and Preventive Action program.
Assist with analysis, trending and reporting of Corporate Internal Audit and External Audit findings.
Perform other activities to support quality system compliance.
Maintain OSTA EU Technical Files.
Maintain and update the Tech files so they remain compliant with current regulatory and company standards.
Maintain and update the clinical evaluation documentation to support EU and international regulations.
Review new standards and regulations as they are issued to determine how they affect OSTA products.
Work with engineering and technical personnel to ensure continued compliance to any revised referenced standards.
Assist with the review and approval of labelling to ensure compliance with applicable regulations.
Assist with regulatory agencies inspections and responses to any findings that may result.
Assist in supporting manufacturing, engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance.
Assist in the development and review of quality system procedures as they relate to compliance.
Conduct risk assessment activities by monitoring and reporting complaint and adverse event trends and data.
Conduct Heath Hazard Evaluations to support field action or recall decisions.
Assist with carrying out recall plans and the tracking and reporting of responses to recalls.
Perform all other duties as assigned.
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The Regulatory Affairs Specialist will help ensure Olympus Surgical Technologies America (OSTA) quality system and EU technical files are compliant with relevant US, EU, Canadian and international medical devices regulations, including ISO 13485, 21 CFR part 820, 93 42 EEC, CMDCAS and others. EOE M/F/D/V
Primary Hiring Locations: Southborough, MA
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 is required, preferably in engineering or life sciences.
Strong knowledge of MDD, ISO 13485, and QSR requirements is required.
Minimum of 3 years of regulatory compliance experience in the medical device industry.
Gyrus ACMI at http://www.gyrusacmi.com/
Evergreen Requisition - Regulatory Affairs Specialist
Reg Affairs/Quality Assurance
Southborough GYR ACMI Inc
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