- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in... environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in... environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is ... to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions… more
- Abbott (Livermore, CA)
- …their health and get on with their lives. This position provides regulatory compliance leadership for the business, ensuring the policies, procedures, and practices ... of the business remain compliant to regulatory and contract requirements. **What You'll Work On** +...processes and programs to ensure business remains compliant to regulatory and contract requirements + In charge of audits… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director, Federal Government Affairs to lead our US federal government engagement...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+… more
- Bristol Myers Squibb (San Diego, CA)
- …role will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs , Supply Chain, Drug Safety/PV, Compliance and Legal). ... milestones, etc. are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …hospital experience. Additional experience within medication or patient safety, quality, regulatory affairs , or medical devices desired Knowledge and Skills ... **Job Description Summary** As Manager, Medical Affairs , you will be responsible for both the...**Responsibilities** + Develops processes and procedures to implement Medical Affairs strategies, including the execution of business operating plans.… more
- ThermoFisher Scientific (Carlsbad, CA)
- …safe or helping find cures for cancer. **Location/Division Specific Information** Within the Regulatory and Clinical Affairs division, we focus on ensuring that ... in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards (national and international). We also ensure that FDA submissions are… more
- Meta (Burlingame, CA)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a ... work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience working with minimal supervision and… more