- MCKESSON (Richmond, VA)
- …activities including adverse event intake, assessment, and regulatory reporting. Collaborate with Regulatory Affairs and Medical Affairs to ensure ... business. The ideal candidate will bring a strong background in quality systems, medical device or pharmaceutical regulations, and team leadership. This is a… more
- Twist BioScience (South San Francisco, CA)
- …at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control, ... a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices, IVD, EU IVDR/MDR,… more
- Oracle (St. Paul, MN)
- …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
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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
- 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_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … 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:** Dec 2,...: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 (Concord, NH)
- …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
- Actalent (Lake Forest, CA)
- …Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , CMC, manufacturing ... 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
- Insight Global (Irvine, CA)
- Job Description A large medical device company is looking for a Regulatory Affairs Coordinator to help with compliance activities. The responsibilities ... not limited to: RA Coordinator I 1) Prepares, dispatches and files routine Regulatory Affairs documentation 2) Collaborates with Regulatory Affairs staff… 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
- 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
- Insight Global (Irvine, CA)
- …A large medical device company is looking for a Sr. Regulatory Affairs Specialist to help with compliance activities. The responsibilities include but ... Strong experience researching, collecting, and addressing requests from regulatory agencies Experience in the Medical Device Industry Bachelor's Degree 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
- 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
