- Olympus Corporation of the Americas (Westborough, MA)
- …implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required. + Site MDR /Regulatory Body Contact. + ... and authoring all worldwide additional information request responses prior to submission to corporate leadership and/or regulatory agencies. This position will… more
- Abbott (Atlanta, GA)
- 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 ... female executives, and scientists **The Opportunity** We are seeking a **Senior Manager Regulatory Affairs** to join Abbott's Heart Failure Division on-site in our… more
- Abbott (Pleasanton, 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 ... executives, and scientists **The Opportunity** We are seeking a **Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site in Pleasanton, CA. As… more
- Proficio, Inc. (Irvine, CA)
- …an award-winning managed detection and response (https://www.proficio.com/managed-detection-and-response-service/) ( MDR ) services provider. We provide 24/7 security ... retail and other industries. Take a video tour (https://youtu.be/s6zP\_TFwTt4) of our global network of 24/7 Security Operations Centers (SOCs). Proficio has been… more
- Actalent (Emerson, NJ)
- Job Title: Quality Manager Job Description We are seeking a dedicated Quality Manager to lead and coordinate regulatory filings, manage quality assurance ... prepare regulatory submissions to regulatory agencies. + Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met.… more
- ThermoFisher Scientific (Rochester, NY)
- …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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …required by the SDLC, and will support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA and EU- MDR . ... development teams on Software development processes and practices. + Working with global cross functional teams, explore and implement harmonization of SW processes… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and best practices in SW design, development, release, and support across the global organization and assists development teams in applying regulatory rigor to Agile ... required by the SDLC and will support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA, PMDA, and EU- MDR… more
- LSI Solutions (Victor, NY)
- …RESUME TO BE CONSIDERED* Do you have experience as an administrative professional, office manager , or clerical assistant? This may be an opportunity for you to take ... review checklists. + Keep up to date with the global regulatory developments of new regulations, standards, policies, and...needed. + Assist in review and compilation of the submission files to obtain market approvals in the USA… more