Job Description

The Manager, Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment and submission of 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, processing and submission of potential adverse events. The Manager, Global MDR Submission works closely with the Global COE MDR team, Market Quality, Legal Manufacturers, SBCs and other departments at the San Jose and Bartlett repair facilities and at the manufacturing sites in US and outside US. The Manager, Global MDR Submission communicates with the FDA or other interested internal and external parties as needed.

This position will also provide MDR SME support for Market Quality as required in close collaboration with Olympus manufacturing sites and other Complaint Handling teams in other regions (Japan, EMEA etc.).

Job Duties

• Manage the daily operations of the COE MDR Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA for all products manufactured or distributed by Olympus entities for events that occur in the United States (US) and for events that occur globally where Olympus has regulatory responsibility for US medical device reporting requirement.

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  Work with Olympus legal manufacturers and Service Centers as needed to resolve adverse event issues and assist with complaints investigations.

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  Establish Key Performance Indicators (KPIs) for the Market Quality COE MDR team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions. Responsible for developing and monitoring tools and provide inputs to Management Reviews where required.

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  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.

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  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 MDR reporting.

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  Maintain all records associated with complaint and MDR submissions files necessary to maintain regulatory compliance including lists and reports.

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  Prepare other types of regulatory submissions to FDA and other interested external parties such as requests for additional information.

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  Support audits of the complaint system and quality processes conducted by FDA, MDSAP and all other external and internal parties.

Job Requirements

REQUIRED QUALIFICATIONS:

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  Bachelor of Science, medical, engineering, or scientific discipline.

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  Minimum of 5 years combined experience in medical device complaint handling, adverse event reporting and/or clinical practice.

• Demonstrated experience leading projects, process improvements and initiatives in post market surveillance or complaint handling/medical device reporting.

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  Up to 10% domestic travel, if not co-located with an Olympus manufacturing and/or service center.

PREFERRED QUALIFICATIONS:

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  Management level experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR) compliance and quality assurance is strongly preferred.

• Experience in MDR reporting highly preferred.

• Demonstrated experience in developing and leading a top performing Quality team is highly preferred.

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  Proficient understanding of medical device regulations both domestic and international with specific expertise in; Internal and External audits, Regulator Inspections, Complaints and Regulatory reporting, US FDA Regulations ( 21 CFR Parts 803, 820, 806) and Corrective and Preventive Actions (CAPA).

• Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms.