Job Description

Job Description

Job Description

Responsibilities:

• Review, assess and maintain US Technical Files, General Safety and Performance Requirements (GSPR) Checklists, Declarations of Conformity and supporting documents so that they are compliance with current regulations and company standards.
• Participate in “state of the art” projects ensuring that new and revised standards are implemented on SG Endoscopy products.
• Participate in sustaining projects that relate to the ongoing maintenance of regulatory compliance for our products.
• Provide regulatory support on the creation and maintenance of clinical evaluations and supporting documents.
• Provide regulatory support on the creation and maintenance of master product data.
• Provide regulatory support or approvals to Quality System and Regulatory workflows (change orders, NCRs, audit findings, CAPAs).
• Support the regulatory department on various other projects, initiatives and tasks.
• 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 (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

We are looking for an excellent team player with professional work ethics to join us for a new exciting role. Successful candidates will be assigned to work on the latest surgical and imaging technologies!

Company Description

We are looking for an excellent team player with professional work ethics to join us for a new exciting role. Successful candidates will be assigned to work on the latest surgical and imaging technologies!

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