- 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 (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
- 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 (Olympia, WA)
- …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
- 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
- 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
- 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
- Bayer (Indianola, PA)
- …Excel, Powerpoint); + Some laboratory experience is highly desirable; + Coursework in medical device development/ regulatory affairs is highly desirable. ... Employees can expect to be paid a salary of approximately between $23.20 to $44.20. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary… 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
- J&J Family of Companies (Raritan, NJ)
- …Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … 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
- 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
- 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
