- 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
- 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
- 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
- Medtronic (Plymouth, MN)
- …planning, submission preparation, all phases of US FDA and EU MDR regulations, global regulatory requirements and procedures, negotiations, product design ... Regulatory Affairs Manager - Peripheral Vascular Health (hybrid) Imagine seeing...new products and therapies and maintain existing products to global markets. A Day in the Life: + Specific… 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
- ThermoFisher Scientific (Waltham, MA)
- …pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and ... of regulatory compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and providing guidance to… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …handling requests for additional information and other post market responses prior to submission to regulators. + Develops a global post market regulator ... requests for additional information from regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible for… more