- Oracle (Oklahoma City, OK)
- …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
- 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
- Medtronic (Santa Rosa, CA)
- …profile._ + Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree ... approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device...heart valve products + Experience with Software as a Medical Device + RAC Medical … more
- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- West Pharmaceutical Services (Exton, PA)
- …to human factors, combination products, delivery system and design controls. + Experience in medical device regulatory affairs and/or design control ... Director, Regulatory Affairs Requisition ID: 71273 Date:...Ability to comprehend principles of math, science, engineering, and medical device use. + Ability to handle… more
- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Senior Regulatory Affairs Specialist **Date:** Nov 3,...:12987 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… 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 (Durham, NC)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... 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. + Effective… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …Tempe, AZ **Preferred Requirements:** + Previous experience in the medical device industry. + Previous regulatory affairs experience, eg, RA ... **Job Description Summary** The Regulatory Affairs (RA) Associate is an...regulatory submissions required to market new or modified medical devices in global markets. The Associate is able… more
- Avania (Boston, MA)
- …are Hiring - Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the ... efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused...Northeastern University Master of Science in Regulatory Affairs students with interest in medical devices.… more
- ManpowerGroup (Beachwood, OH)
- …a leading organization in the medical device industry, is seeking a ** Regulatory Affairs Specialist** to join their team. As a Regulatory Affairs ... field. + 4+ years of experience in a regulated industry, preferably in Regulatory Affairs or medical devices. + Strong written and verbal communication… more
- Actalent (Lake Forest, CA)
- … Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , FDA CFR, CMC, ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global ...development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU… more
- Kelly Services (Bridgewater, NJ)
- …regulatory approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle ... ** Regulatory Affairs Specialist Labeling** Kelly(R) Science...+ **SPECIFIC SKILLS** + Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for… 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... abilities and a deep understanding of regulations pertaining to medical devices. The Senior Regulatory Affairs...of related regulatory submission experience from a medical device and/or IVD industry. + Ability… more
- Dentsply Sirona (Sarasota, FL)
- …**Years and Type of Experience:** + 8(+) years of experience in regulatory affairs , preferably in the medical device industry + Experience with leading ... oral health worldwide. **Job Summary:** **The Senior Manager of Regulatory Affairs supports regulatory ... activities for US FDA 510k submissions, Health Canada medical device licenses, and EU Technical Files.… 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... focus on regulatory affairs . + 3+ years of related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a… more
- J&J Family of Companies (Cincinnati, OH)
- … documents (eg CFG) to support global expansions or tenders. + Have Regulatory Affairs experience in the medical device industry with a track record of ... the best talent for a **Senior Regulatory Affairs Specialist** to support our Torax Medical ...Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance,… more