- Teva Pharmaceuticals (Parsippany, NJ)
- Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Nov 17, 2024 Location: Parsippany, United States, New Jersey, 07005 Company: ... live better, healthier lives. **The opportunity** As a **Director, in Global Regulatory Medical Writing (GRMW)** , you will primarily work in a therapeutic area… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Senior Manager, US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA or Exton, ... PA** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director, Global Regulatory Medical Writing & Data Transparency Date: Oct 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership, direction, and… more
- AbbVie (Irvine, CA)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the ... management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities,… more
- Amazon (Bellevue, WA)
- …part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The ... is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling...Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe,… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …as medical writing contributor or lead for clinical trial-related regulatory documents + Write/edit/review content of clinical trial-associated documents for new ... timelines for all assigned documents **Basic Qualifications** Master's and 3+ years of medical / regulatory writing experience OR Bachelor's and 5+ years of … more
- Caldera Medical (Westlake Village, CA)
- …Medical 's Mission - To Improve the Quality of Life for Women! As a regulatory specialist, you will develop and implement medical device regulatory ... ASQ, CQE preferred. * 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry. * Experience with Class II medical… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Required/Preferred Education and Experience + Degree in Regulatory Affairs or Regulatory Affairs Certification preferred + Experience with medical device ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- LSI Solutions (Victor, NY)
- …skills in a wide variety of tasks. Regulatory Associates provide regulatory feedback and guidance based on medical device regulations and standards ... all standards that govern the design, development, manufacturing, and distribution of our medical devices. ESSENTIAL FUNCTIONS: Regulatory Associates I and II: +… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …or Science (or similar) is required. Master's degree preferred. + Experience in medical device Regulatory Affairs, Quality Assurance, or Research & Development ... management activities. + Has a broad understanding of the global medical device regulatory landscape, regulatory submissions (eg, 510(k), CE Mark etc),… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …health care-related discipline required. + 3 -5 years of experience in Medical devices regulatory submissions required. + Experience with successful preparation ... **Job Description:** **JOB SUMMARY:** Responsible for regulatory assessments, coordination and preparation of document packages for regulatory submissions (FDA,… more
- AbbVie (Irvine, CA)
- …equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs. + Experience in US medical devices regulatory affairs is ... documents, as well as technical reports, in support of regulatory submissions. + Advanced knowledge of US/EU medical... regulatory submissions. + Advanced knowledge of US/EU medical device regulations. + Ability to function in a… more
- Teleflex (Chelmsford, MA)
- …a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of ... Sr. Regulatory Affairs Specialist **Date:** Nov 21, 2024 **Location:**...:11196 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Teleflex (Morrisville, NC)
- …field, or equivalent work or educational experience. * 7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent ... Principal Regulatory Affairs Specialist **Date:** Nov 1, 2024 **Location:**...:11132 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Medtronic (Minneapolis, MN)
- …profile._ + Bachelor's degree in a technical discipline + Minimum 4 Years of medical device regulatory experience with Bachelor's degree + Or minimum 2 Years ... of medical device regulatory experience with an advanced degree **Nice To Have** + Experience working in regulated, biotechnology environment, including… more
- Englewood Lab, Inc (Totowa, NJ)
- …degree (Life Sciences, Engineering, related profession) + Experience of drug, cosmetic, medical device regulatory process is a pre-requisite + Familiarity with ... Title: Regulatory Affairs Associate Reports to: Manager of ...industry or related experience in any combination of cosmetic, medical device, food, or pharma is required. + Previous… more
- Stryker (Mahwah, NJ)
- …or related degree required + Minimum of 2 years of experience in medical device regulatory affairs required + Time management skills, writing, coordination, ... of Stryker's joint replacement implant devices. You will author regulatory submissions for both the US and global regions,... Affairs) preferred + Knowledge of FDA and international medical device regulations and standards (eg EU MDR) preferred… more
- Medtronic (Boston, MA)
- …years of experience in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing to work ... Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic...be responsible for modifying existing products, preparing and submitting regulatory filings for the US market and managing EU… more
- BeiGene (Emeryville, CA)
- …partners for device use and filings/registrations as applicable. + Maintain IVD medical device regulatory knowledge and advise management and related ... **General Description:** The Senior Manager, Regulatory Diagnostics will lead the development, planning, and execution of IVD related regulatory deliverables in… more