- Olympus Corporation of the Americas (Center Valley, PA)
- …for process improvement and waste removal. + Key Team player working closely with other Global MDR Submission Associates + Perform other duties as assigned ... global complaints involving Olympus products, preparation, and submission of manufacturer / importer MDR reports...requires general instruction for new or special assignments from Manager . The Global MDR Analyst… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Global MDR Submissions Analyst III. Hiring Location: US **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
- Stryker (Fremont, CA)
- …study reports, regulatory-required routine reports, publications, podium clinical presentations, MDR -specific deliverables, CER/CES, etc. to the Global NV ... few. + All processes related to CER/CES generation for MDR , NMPA and other global regulators requiring...of all mandatory training and quality obligations with HR Manager . Creates training plans and tracks completion of mandatory… more
- Philips (Chicago, IL)
- …on the preparation and submission of 510K's, PMA's and experience with EU MDR /MDD, Health Canada, China, etc. + You have a strong background in Design Controls. ... The Senior Regulatory Affairs Program Manager will play a critical role in ensuring...detailed knowledge of medical device regulations (21CFR), FDA law, MDD/ MDR , other global laws, regulations and standards… more
- AbbVie (Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of the Clinical Trial Strategy and Submission delivers clinical ... EEMEA, LA and specified JAPAC countries in alignment with the overarching global regulatory strategy and region-specific requirements. + Ensure the submission … more
- ICU Medical (UT)
- …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
- Teleflex (MA)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Sep 26, 2024 **Location:** Remote, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... **Requisition ID** :11022 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and / or regulators. The position will ensure ... internal and external responses. + Reviews and authors responses prior to submission to Corporate Compliance and/or regulators + Tracks, trends, and analyzes audit… more
- Medtronic (Boulder, CO)
- …can thrive. We are seeking a dynamic and innovative Research and Development (R&D) Manager to oversee the development of technology and products in Acute Care and ... Drive the patenting process for new inventions and technologies. + Support the submission of scientific articles and presentations both internal and external to the… more
- Bausch Health (San Francisco, CA)
- …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
- 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 ... Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities. + Responsible for compiling the… more
- Medtronic (Minneapolis, MN)
- …+ 4+ years of medical device industry experience with US FDA 510(k) and EU MDR submission experience. + Proven expertise in all aspects of Regulatory Affairs; ... Regulatory Affairs Manager . **Role And** **Responsibilities:** + Develop and support global regulatory strategies for Class I, II, and Class III ablation therapy… more
- West Pharmaceutical Services (Exton, PA)
- …regulatory affairs (RA) team's priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information request responses, ... responsible for management of regulatory affairs projects associated with West's global portfolio of medical devices, combination products, SaMDs, and packaging… more
- Caldera Medical (Westlake Village, CA)
- …ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. * Reviews ... project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our Westlake Village location and… more