- Olympus Corporation of the Americas (Westborough, MA)
- …purpose and our core values by staying **True to Life.** **Job Description** This position, the Manager of Global MDR Submissions, manages the Global ... timely review and processing of potential adverse events. The Global MDR Submissions Manager works...investigations. + Establish Key Performance Indicators (KPIs) for the Global MDR Submissions Submission team… more
- ICU Medical (Lake Forest, IL)
- …is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new products and changes to existing ... the Infusion Systems business. Develop high quality US, EU MDR and global regulatory submissions that continue...benefit in regulatory strategies to ensure successful review by global regulatory authorities. * Directs submission related… more
- Medtronic (Northridge, CA)
- …ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. + Reviews ... product introduction (NPI) and marketed products under MDD and MDR Regulation. Work with RAS, engineers, and technical experts...level. All significant issues will be reviewed with the manager . + Maintain proficiency in global regulatory… more
- Medtronic (Boulder, CO)
- …of medical device regulatory submission experience. + US and EU regulatory submission experience (510k and EU MDR ) + Experience with international standards ... Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals… more
- Abbott (St. Paul, MN)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... more than 160 countries. **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people's...**The Opportunity** We are recruiting for a **Regulatory Affairs Manager ** to join our team in St. Paul, MN.… more
- Stryker (District Of Columbia, DC)
- …Under general supervision of the RA Project Manager or RA Department Manager or Director. + Responsible for EU MDR remediation and sustenance strategy. ... more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Stryker is a global leader in medical technologies and, together with its… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... monitor their glucose levels with our new sensing technology. As the Field Action Manager you will initiate and execute Field Action related activities and is a key… more
- Zimmer Biomet (Warsaw, IN)
- …in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced ... unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards + Creates product… more
- Zimmer Biomet (Warsaw, IN)
- …in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced ... and to reduce user risk in compliance with company procedures and global regulatory requirements. * Support Quality, Sourcing and Manufacturing teams with new… more
- Medtronic (Mounds View, MN)
- …as required, to ensure timely approvals. Review significant product submissions with manager and negotiate submission issues with agency personnel. + Provide ... We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions Careers that Change Lives The Principal… more