Evergreen Requisition - Global MDR Submissions Analyst III

at  Olympus Corporation of the Americas

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Olympus is looking for Global MDR Submissions Analyst III.
Hiring Location: US

JOB DESCRIPTION

As a Global MDR Submission Analyst III OSTA team member, you will be responsible for the review of medical device global complaints and coordinate the resolution of complex complaints (For example: death, serious injury, legal papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and 21CRF803 and will also have a an understanding of global adverse event reporting criteria (For example: Europe, China, Australia, Latin America, Japan, and others). The Analyst III assists with reportable determinations for OSTA products and performs clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is required. Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and mentors lower level staff; initiates new or special assignments with occasional direction from Manager.

APPLICANTS WITH DISABILITIES:

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Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA

• A seasoned, experienced professional with a full understanding of complaint handling.
• Reviews complex complaints such as death, serious injury, legal papers, and literature reviews for medical devices independently.
• Ensures complaint files have an appropriate resolution and/or justification.
• Acts as a resource for department staff members on complex complaints.
• Completes Clinical Assessments for complex cases and upon request, when appropriate.
• Prepares and reviews MDRs/Supplemental reports for the FDA for complex complaints Monitors progress of all ongoing complaint activities and MDRs to ensure the timely submissions.
• Provides training during orientation and on-boarding of new staff.
• Mentors staff members regarding complaint processing.
• May provide assistance to junior level staff with general tasks that require a better understanding.
• Processes reportability decisions and is able to complete MDR submissions.
• Assist in the preparation of regulatory body additional information requests.
• Functions as a team member/ leader in collaboration.
• Lead/Manage special assignments/ projects with Global MDR Submission or across functional areas.
• Other duties as assigned