- Terumo Medical Corporation (Los Angeles, CA)
- …on Interactions with Healthcare Professionals. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. 12. ... Performs other job-related duties as assigned. **Job Responsibilities (continued)** **Working Conditions/Physical Requirements** 1. This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive… more
- Medtronic (Santa Rosa, CA)
- …connected, compassionate world. **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team ... environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory. This will be an...years of experience **NICE TO HAVE:** + Experience with FDA and FTC advertising and promotion regulations + Medical… more
- Parexel (Sacramento, CA)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs… more
- Sumitomo Pharma (Sacramento, CA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- MetaOption, LLC (Sunnyvale, CA)
- …ensure reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards for healthcare data protection. You ... incident lifecycle (detection, triage, resolution, postmortem), documenting as required for FDA compliance and audit readiness. * Develop and maintain incident… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …promoting department personnel.Strict adherence to procedures and practices according to FDA regulations.Strong emphasis on documentation according to FDA ... Minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. Aseptic experience is required.Equivalency: + In lieu of… more
- Parexel (Sacramento, CA)
- …development. * Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. * Collaborate with global teams to ... ensure consistency across markets while meeting US-specific requirements. * Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. * Support… more
- Hologic (San Diego, CA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards,… more
- Abbott (San Diego, CA)
- …development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and ... activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software implementation are… more
- J&J Family of Companies (Santa Clara, CA)
- …ISO 14971 processes. + Stay current with **global regulatory changes** (EU MDR, FDA , China NMPA, etc.) impacting EMC and safety compliance and communicate updates to ... **cybersecurity implications** for connected medical devices. + Working knowledge of ** FDA 510(k)** and **EU MDR Technical File** processes. **Core Competencies:** +… more
