- Teleflex (Dallas, TX)
- Clinical Affairs Manager , Interventional Access (REMOTE) **Date:** Oct 11, 2025 **Location:** dallas, TX, US **Company:** Teleflex **Expected Travel** : Up to ... **TRAVEL REQUIRED: 50% (Domestic and International; overnight required)** The Clinical Affairs Manager will provide clinical expertise, insight, and support… 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
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… 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, 'One GRA ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job...one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with… more
- CSL Behring (King Of Prussia, PA)
- … regulatory outcomes.** **-** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...key region (EU, US, Japan)** **-** **Experience working in Regulatory Affairs with agency interaction responsibility with… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution of complex complaints… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... Analyst II OSTA team member, you will be responsible for timely regulatory reporting assessments and reassessments of global complaints, preparation and submission… more
- Terumo Medical Corporation (Elkton, MD)
- Manager , VS Quality Engineering Date: Oct 4, 2025 Req ID: 5143 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Engineering ... part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... **13014BR** **Title:** Engineering Manager R&D **Job Description:** Manage individuals from entry-level...six (6) years of relevant work experience in medical device industry. 3. Minimum one (1) year of management… more
- Integra LifeSciences (Plainsboro, NJ)
- …from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed to evaluate, analyze, ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,...years Medical Safety, risk management Vigilance or other Medical Device Experience (Medical Device preferred to Pharma)… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for ... and product marketing strategy for product portfolio which been assigned. + Regulatory affairs professionals actively participate on NPI (new product… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical device… more
- Dentsply Sirona (Milford, DE)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...EU MDR). + Experience with software as a medical device , AI and/or medical devices containing software is a… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international… more
- United Therapeutics (Research Triangle Park, NC)
- …the back of your hand - you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead the preparation, compilation, and ... for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives to devise...discipline + 8+ years of direct experience with a regulatory affairs CMC role with a bachelor's… more
- Medtronic (Irvine, CA)
- … Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs . + **510(k) Submission Experience:** Proven history ... a minimum of 2 years of experience in medical device regulatory affairs is a...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Medtronic (Santa Rosa, CA)
- …in a technical discipline + Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or advanced ... degree with a minimum of 5 years of Regulatory Affairs experience. + Medical device...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- GE HealthCare (Chicago, IL)
- …as medical devices, pharmaceuticals, or biologics. + A minimum of 5 years' experience in Regulatory Affairs . + A minimum of 5 years' experience in regulatory ... life supporting, and life-sustaining products. + Advanced degree in scientific, technology or regulatory affairs disciplines. + Regulatory Affairs … more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... device industry, or equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably with… more