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Global MDR Submission Manager
Location:
Westborough, MA
Description:
Working Location:MASSACHUSETTS, WESTBOROUGH Workplace Flexibility:Field Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years. Our Purpose is to make people's lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View We deliver on our purpose and our core values by staying True to Life. Job Description This position, the Manager of Global MDR Submissions, manages the Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide in conformance with applicable local, regional and international regulations. This position manages and directs these activities ensuring the timely review and processing of potential adverse events. The Global MDR Submissions Manager works closely with technical staff in Global MDR Submissions and other departments at the San Jose and Bartlett repair facilities and at the manufacturing sites. The Global MDR Submissions Manager communicates with the FDA or other interested internal and external parties as needed. id541__section_lib: Job Duties: Manage the daily operations of Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA.: Manage the daily operations of Global MDR Submissions Analysts who are responsible for overseeing and approving adverse event and vigilance reports associated with OSTA products sold or distributed internationally.: Monitor complaint activities associated with OSTA products worldwide to ensure timely submissions in all markets.: Work with local OSTA distributors as needed to resolve adverse event issues and assist with investigations.: Establish Key Performance Indicators (KPIs) for the Global MDR Submissions Submission team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions.: Work with QARA Management from throughout Olympus to improve and streamline processes and systems (e.g. EtQ, SAP, Datasweep, etc.) needed to support both local and global targets and objectives.: Work with the Post:Market Surveillance department to establish tools and methods needed to monitor external sources of information such as media reports and clinical studies that may require complaint investigation or follow:up.: Maintain all records associated with complaint and MDR submissions files necessary to maintain regulatory compliance, including lists and reports.: Prepare other types of regulatory submissions to FDA and other interested external parties such s requests for additional information.: Support audits of the complaint system conducted by FDA, MDSAP and all other external and internal parties.: Perform other duties as required. Job Qualifications Required: : Work experience must include a strong concentration in QSR compliance and complaint processing activities.: Must have a minimum of 10 years combined experience in medical device complaint handling, medical device adverse event reporting and/or clinical experience. Preferred: : Clinical background strongly preferred. LI:Remote Why join Olympus? Here, people matter-our health, our happiness, and our lives. : Competitive salaries, annual bonus and 401(k)* with company match: Comprehensive Medical, Dental, Visions coverage effective on start date: 24/7 Employee Assistance Program: Free virtual live and on:demand wellness classes: Work:life balance supportive culture with hybrid and remote roles: 12 Paid Holidays: Educational Assistance: Parental Leave and Adop
Posted:
June 11 on Tip Top Job
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More About this Listing: Global MDR Submission Manager
Global MDR Submission Manager is a Executive Manager Job located in Westborough MA. Find other listings like Global MDR Submission Manager by searching Oodle for Executive Manager Jobs.
Global MDR Submission Manager is a Executive Manager Job located in Westborough MA. Find other listings like Global MDR Submission Manager by searching Oodle for Executive Manager Jobs.