- IQVIA (Durham, NC)
- …with operations guidance. + Provide 'second opinions' where appropriate. + Escalates issues to medical director where appropriate. + Be a leader and role model ... research design, methods, and outcome measures. + Advanced knowledge of pharmaceutical and medical device guidelines and regulations. + Experience on an approval… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …+ Advance degree preferred. + Preferred minimum of 10-15 years of experience in the medical device industry, with at least ten years in a regulatory role. + ... (scientific and legal); and negotiate with Regulators. + Ability to interpret medical device testing methods and statistics, as applicable. + Knowledgeable… more
- Gilead Sciences, Inc. (Foster City, CA)
- …communication skills are required. + Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms. + Demonstrated ability ... device combination product design and development from feasibility, clinical development, through registration, and post-market. This includes requirements… more
- Oura (San Francisco, CA)
- …digital health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Director , New Product Planning & Drug Delivery Innovation, will serve an ... asset pipeline and portfolio. This role will span across the Device Engineering, Primary Container, Process Development, Packaging, and Labeling functions, and… more
- Bayer (Whippany, NJ)
- …Minimum of a Bachelor's degree; + At least 5 years of relevant experience in US medical device or healthcare marketing, with at least 3 years of experience in ... post-market evidence strategy by identifying relevant marketing endpoints and collaborating with clinical and medical teams to translate data into impactful… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team....Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …experience, including a minimum of 5-7 years in the pharmaceutical/biotechnology or medical device industry. + In-depth knowledge of (US) healthcare systems, ... analysis, econometric modelling, and real-world outcomes research in the pharmaceutical/biotechnology or medical device industry. + Senior level competence in US… more
- Edwards Lifesciences (Irvine, CA)
- …or related field with 15+ years of relevant Engineering experience with 10+ years in medical device -OR- + Master's degree in engineering or related field with ... (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported...years of relevant Engineering experience with 10+ years in medical device + 5+ years of experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more