- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Manager , Senior Global MDR Submission is responsible for managing Market Quality- COE ... review, processing and submission of potential adverse events. The Manager , Sr. Global MDR Submission works closely with the Global COE MDR … more
- Olympus Corporation of the Americas (Westborough, MA)
- …our purpose and our core values by staying **True to Life.** **Job Description** As a Global MDR Submission Analyst III OSTA team member, you will be ... as a team member/ leader in collaboration. + Lead/Manage special assignments/ projects with Global MDR Submission or across functional areas. + Other duties… 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
- Philips (San Diego, CA)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA function to ... management, including the development of global regulatory strategy in the area of regulatory submissions....and product registrations, clinical evaluations in accordance with EU MDR , ISO 13485 and ISO 14155, China NMPA, Canadian… more
- J&J Family of Companies (Irvine, CA)
- …supervisory experience. * Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA and EU MDD/ MDR 93/42/ECC Device Law/Regulations, ... Manager , Regulatory Affairs - Biosense Webster, Inc. -...at_ _https://www.jnj.com/.\_ **DUTIES & RESPONSIBILITIES** * Ensure compliance with global regulations and regulating agencies. Interpret the intent of… more
- Stryker (Allendale, NJ)
- …Under general supervision of the RA Project Manager or RA Department Manager or Director. + Responsible for EU MDR remediation and sustenance strategy. ... Why RA/QA at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of… 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
- Bausch Health (Bothell, WA)
- …and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations for their ... closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective execution and management… more
- Zimmer Biomet (Jacksonville, FL)
- …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 ... **What You Can Expect** You have a design owner and/or project manager role with responsibility for new product design, development, and commercialization; and/or… 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 ... **What You Can Expect** You have a design owner and/or project manager role with responsibility for new product design, development, and commercialization; and/or… more
- Medtronic (Mounds View, MN)
- …timely approvals for market release. + 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. Cardiac Surgery seeks two senior regulatory… 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