- Oracle (Montpelier, VT)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Stryker (Redmond, WA)
- … Regulatory Affairs ). + Previous experience with US Class II/III medical devices . + Experience authoring regulatory submissions for product approval. ... based **Hybrid** in **Redmond, Washington.** As part of the Medical Regulatory Affairs team, you...team, you will work with the team to maintain medical devices on the market and ensure… more
- Terumo Aortic (Sunrise, FL)
- …(or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct ... experience in medical device regulatory affairs if no...and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record… more
- Cardinal Health (Waukegan, IL)
- …+ 1-3 years Regulatory Affairs experience, preferably in the Medical Device industry + Strong proficiency in Microsoft Office Applications preferred + ... Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions...provide regulatory support on a range of medical devices . Job responsibilities include support of… more
- Cardinal Health (Mansfield, MA)
- …years Regulatory Affairs Experience, preferred + Majority of Regulatory Affairs experience in Medical Device industry preferred + You may be ... Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions...provide regulatory support on a range of medical devices . Job responsibilities include regulatory… more
- Cardinal Health (Juneau, AK)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**...Brand, Presource, and Sustainable Technologies businesses and range of medical devices . + Maintain regulatory … more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- Sanofi Group (Morristown, NJ)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- Abbott (Alameda, CA)
- …process. + 3+yearof Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or ... SharePoint. + Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs ,… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and support continuous clinical education. + Contributes to cross-functional partnerships between Medical Affairs , Commercial, Regulatory and R&D, and ... Medical Affairs , Clinical, Strategy or Marketing role(s) within the medical device or pharmaceutical industry. + Demonstrated experience in both… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. + ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting… more
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- GRAIL (Albany, NY)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Access Dubuque (Dubuque, IA)
- …manufacturer of single-use medical devices , is seeking a quality-driven Regulatory Affairs Specialist to join our team. This person will work directly ... development projects for the domestic and international markets for medical devices . Prepares and submits, registrations, licensing,...related field with 1-3 years of regulatory affairs , quality, or medical device … more
- Kelly Services (Norcross, GA)
- …area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: ... Regulatory Affairs professional to manage pre-market regulatory activities for medical devices ,...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
- Abbott (Plymouth, MN)
- …etc.), math, engineering, or medical fields. + Master's degree in Regulatory Affairs . + Regulatory experience with capital equipment including ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist ... for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must...reagent chemistry, laboratory automation, and software components of IVD medical devices . + Strong oral and written… more