- 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
- Cardinal Health (Raleigh, NC)
- …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
- 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
- Dentsply Sirona (Charlotte, NC)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...13485, EU MDR). + Experience with software as a medical device , AI and/or medical … more
- Teleflex (Morrisville, NC)
- Sr Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... challenges in the market for materials used in the medical device industry, coupled with commercial and...cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on supporting… 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
- IQVIA (Durham, NC)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… 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
- Lilly (Durham, NC)
- …include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs **Additional Preferences:** + Broad knowledge of ... This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (… 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
- Edwards Lifesciences (Raleigh, NC)
- …Bachelor's Degree in a related field with 5 years of related experience working in medical affairs , clinical affairs and/or clinical science **What else we ... internal/external working relationships + The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment… more
- Dentsply Sirona (Charlotte, NC)
- …studies. + 3+ years prior experience in clinical affairs , regulatory affairs , and/or clinical research for AI/ML enabled medical device software. ... CERs and study protocols (eg multi-reader multi case studies) for AI enabled medical device software. **Qualifications / Background:** + Higher education in… more
- ThermoFisher Scientific (Greenville, NC)
- …and ongoing refinement of the Quality Management System for the company's worldwide medical device and combination product portfolio. This role ensures adherence ... proactive updates to the QMS. **Cross-Functional Leadership** + Collaborate with R&D, Regulatory Affairs , Manufacturing, and Supply Chain to embed quality… more
- Edwards Lifesciences (Raleigh, NC)
- …related field plus 12 years of experience in health policy, health economics, medical device reimbursement and technology assessment or master's degree plus 10+ ... as a supporting role to our aligned business partners including sales, marketing, government affairs , and medical /clinical affairs . + Assist our Regional and… more
- Teleflex (Morrisville, NC)
- …collaboration with Marketing Communications (MarCom), Product Marketing, Clinical and Medical Affairs , Legal/Compliance, Regulatory , and other ... * Marketing Directors * Marketing Communications * Clinical and Medical Affairs * Legal * Regulatory...Bachelor's degree * 5+ years of digital marketing experience ( medical device , healthcare, or other regulated industry… more
- Edwards Lifesciences (Charlotte, NC)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… 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