- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development… more
- Teleflex (Morrisville, NC)
- Sr Regulatory Affairs Specialist **Date:** Oct 22, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on supporting...program implementation plans. - Manage Technical Documentation. - Manage Global regulatory impact assessments. - Review and… more
- Parexel (Columbia, SC)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as...development plans. + Act as the representative of European regulatory team at the global regulatory… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... cross functions on the team to ensure alignment of global regulatory strategy with the team objectives....solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects… more
- Olympus Corporation of the Americas (Washington, DC)
- …science, or related field preferred. + Minimum 15+ years of experience in government affairs , public policy, or regulatory strategy, with 5+ years in healthcare, ... . **Job Description** This position will establish and lead the US government affairs function for Olympus. This leadership role ensures the company has a strategic… more
- Teleflex (Minneapolis, MN)
- …with Teleflex IPPs. - Coordinate efforts between cross-functional partners, including Medical Affairs , Global Research & Scientific Services, marketing, and R&D. ... clinical exposure in the medical field in the Cardiology environment. - Medical Device industry supporting Clinical and Medical Affairs , strongly preferred. -… more
- GRAIL (Durham, NC)
- …limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs , Compliance, ProgramManagement, ClinicalAffairs, Supply Chain, ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... business insights / analytics and other specialized regulatory functions (eg, device /combination products) to deliver Global Regulatory Strategy Outlines… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …(https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution of ... and 21CRF803 and will also have an understanding of global adverse event reporting criteria (For example: Europe, China,...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- CSL Behring (King Of Prussia, PA)
- …of successful regulatory outcomes.** **-** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other ... as needed.** **-** **Proactively fosters and promotes effective relationships across Global Regulatory Strategy. Updates and maintains applicable regulatory… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements. The Global Vice President QARA Compliance is ... internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates...recommendations. + Coordinates and leads audit activities with all global regulatory agencies (eg FDA, Notified Bodies,… more
- embecta (Parsippany, NJ)
- … changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR ... to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams to ensure… more
- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… more
- Teleflex (Chelmsford, MA)
- …ongoing risk management activities for supported products - Partner with R&D, Marketing, Regulatory Affairs , and Operations to support activities in product and ... the NC and CAPA systems as needed to structure activities. - Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. - Partner… more
- Cordis (Miami Lakes, FL)
- …future product launches. + Operate cross-functionally with Commercial, Marketing, R&D, Clinical Affairs , Regulatory , and Quality to align messaging and maintain ... of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart… more
- Lundbeck (Deerfield, IL)
- …in development by providing substantive advice to US operations, including Marketing, Medical Affairs and Regulatory Affairs departments, concerning a broad ... you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …tracking, review, and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and milestones by managing ... and maintaining study tackers and logs. + Manages device accountability for clinical studies, including tracking, shipment, and reconciliation of devices. +… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …in internal and external audits. Cross-Functional Collaboration Collaborate closely with Sales, Regulatory Affairs , Logistics, Finance, and Supply Chain to align ... Title : Manager, Customer Service Supervisor/Manager Title: Senior Director of Global Commercial Operations and Strategy Job Description Summary: The Customer… more
- Teleflex (Morrisville, NC)
- …representative during acquisitions, collaborating with teams in Quality Assurance, Regulatory Affairs , Supply Chain, Design, and Manufacturing. Additionally, ... representing supplier quality in cross-functional projects to meet company and regulatory goals. **Principal Responsibilities** - Coordinate with Global … more
