- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to be located ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Dec 16, 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: Dec 28, 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
- J&J Family of Companies (Spring House, PA)
- …and retinal disease. We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Immunology therapeutic area. The ... across J&J Immunology programs. This role will report directly to the Regulatory Medical Writing Delivery Unit Head, Immunology. + Is the primary point of… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …updates. We are a lean team that thrives on partnership with our colleagues. US Medical Ad/Promo Regulatory 2025 Intern will learn how to apply broad FDA ... responsibilities for key functions involved in or that impact Ad/Promo, including Medical , Legal, Marketing, Compliance, Labeling and Regulatory Strategy. + May… 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
- LSI Solutions (Victor, NY)
- …gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, ... that govern the design, development, manufacturing, and distribution of our medical devices. REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS: Level… 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
- Abbott (Pleasanton, CA)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... device regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Cardinal Health (Columbus, OH)
- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will ... provide regulatory support on a range of medical devices. Job responsibilities include regulatory lead...range of medical devices. Job responsibilities include regulatory lead for change development projects, new product development,… 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
- 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
- J&J Family of Companies (Cincinnati, OH)
- …include Science, Engineering, or related field. + Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with ... Advanced Degree). + Experience with medical device regulatory new product submissions required. + A demonstrated track record of developing and driving… 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
- Medtronic (Minneapolis, MN)
- …are evident in your applicant profile._ + Bachelors degree + Minimum 4 years of medical device regulatory experience, + Or advanced degree with a minimum of 2 ... years medical device regulatory experience **Nice to Have (Preferred Qualifications):** + Experience in operations with regulatory affairs or quality +… more
- Stryker (Mahwah, NJ)
- …Science, or related degree + Minimum 2 years of work experience in medical device regulatory affairs + Time management skills, writing, coordination, and ... benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Joint Replacement**… 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
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