Olympus Corporation of the Americas Senior Manager, Global MDR Submission in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH; Nationwide
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The Manager, Senior 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, Sr. 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, Sr. 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.).
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.
Work with Olympus legal manufacturers and Service Centers as needed to resolve adverse event issues and assist with complaints investigations.
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.
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 MDR reporting.
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 as requests for additional information.
Support audits of the complaint system and quality processes conducted by FDA, MDSAP and all other external and internal parties.
Bachelor of Science, medical, engineering, or scientific discipline.
Minimum of 10 years 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.
Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses.
Demonstrated experience in developing and leading a top performing Quality team is required.
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.
Up to 10% domestic travel, if not co-located with an Olympus manufacturing and/or service center.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||
Olympus Corporation of the Americas
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