- Oracle (Raleigh, NC)
- …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 (Raleigh, NC)
- …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
- GRAIL (Durham, NC)
- …, 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
- BD (Becton, Dickinson and Company) (Durham, NC)
- …**Minimum Requirements:** + Bachelor's degree + Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic ... This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy...of Pharmacy, and Environmental requirements + Working knowledge of medical device stand-alone software, device … more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …related to licensing activities, Source Plasma collection and medical device regulations. + Maintain up-to-date knowledge of regulatory requirements and ... and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Fujifilm (Raleigh, NC)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- GRAIL (Durham, NC)
- …management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with ... not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs , Compliance, ProgramManagement, ClinicalAffairs, Supply Chain,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in pharmaceutical quality, with specific experience ... TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Disclaimer** This job description is intended to describe… more
- Teleflex (Morrisville, NC)
- …representative during acquisitions, collaborating with teams in Quality Assurance, Regulatory Affairs , Supply Chain, Design, and Manufacturing. Additionally, ... preferred * 5-10 years of experience working within an FDA regulated industry, Medical Device preferred * Advanced problem solving and root cause analysis… more