- Terumo Aortic (Sunrise, FL)
- …with corporate procedures and timely product approvals with domestic and international regulatory requirements. POSITION IN ORGANISATION Position in organisation ... Regulatory Affairs Associate II Date: Nov 16, 2025...patients in over 100 countries worldwide. www.terumoaortic.com JOB TITLE Regulatory Affairs Associate II DEPARTMENT Regulatory Affairs… more
- Philips (Colorado Springs, CO)
- …+ You have familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards, regulations, and submission paths. + You have a ... The Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design and manufacturing changes, and sustaining… more
- Olympus Corporation of the Americas (Westborough, MA)
- …is desirable. + Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a Medical Device highly desirable. ... . **Job Description** This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth,… more
- West Pharmaceutical Services (Exton, PA)
- …systems. + Regulatory compliance competency including Quality Systems + International regulatory competency + Advanced degree **License and Certifications** ... Director, Regulatory Affairs Requisition ID: 71273 Date: Nov 6,...Date: Nov 6, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This is a hybrid position requiring… more
- Meta (New York, NY)
- …Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical devices...issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits, post-market vigilance… more
- Cook Medical (Bloomington, IN)
- …development of regulatory documentation for compliance with FDA and international regulatory requirements. Responsibilities - Act as liaison to engineering ... Overview The Regulatory Engineer provides technical support to Regulatory...functions globally and locally to provide technical support for Regulatory Affairs- Develop new, and refine existing, systems that… more
- Globus Medical, Inc. (Audubon, PA)
- …in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and ... as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining...achieves timely regulatory clearance/approval for marketing. + Develops Regulatory … more
- Terumo Neuro (Aliso Viejo, CA)
- …activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing,...Job duties: + Represent Regulatory on project teams and partner with the cross… more
- Medtronic (Irvine, CA)
- …new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct + ... 4 years of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling, or an… more