- 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
- Oracle (Phoenix, AZ)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… 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 degree. + Knowledge of US and European regulatory processes, including Class III is strongly… more
- Actalent (Miami, FL)
- …skills. Additional Skills & Qualifications + Knowledge of FDA regulations. + Experience in medical device regulatory affairs . + Bilingual proficiency. + ... Job Title: Regulatory Affairs Specialist Job Description We...+ Oversee Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements. + Responsible for device registration… 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
- 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)
- …Science, Biology, Chemistry, or related field with 1-3 years of regulatory affairs , quality, or medical device experience. Lead Auditor experience ... single-use medical devices, is seeking a quality-driven Regulatory Affairs Specialist to join our team....compliance to ISO 13485, FDA 21 CFR 820, and Medical Device Single Audit Program. Lead the… more
- ManpowerGroup (Maplewood, MN)
- …of experience in regulatory affairs within the pharmaceutical or medical device industry, including experience with combination medical devices. + ... Our client, a leading organization in the medical device and pharmaceutical industry, is seeking a Regulatory Affairs Lead to join their team. As a … more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for … 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 communication and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. + Minimum of 3 years focused on ... beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's Transfer Devices ... Sr. Specialist Regulatory Affairs , MD Requisition ID: 71773...with 5+ years; Master's degree/PhD with 3+ years of medical device , pharmaceutical or regulatory … more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 ... Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + ... solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory guidance,… more
- Pentax Medical (Montvale, NJ)
- …devices 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...biocompatibility requirements + Proven track record in writing major regulatory device submissions (ie 510(k)s), with the… 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
- J&J Family of Companies (Raritan, NJ)
- …coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This ... Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and can… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… 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...activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of… more