- 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
- Medtronic (Irvine, CA)
- …software - Part 1: General requirements for product safety + United States FDA Device Software Functions related Guidance's + United States FDA Interoperability ... - Security Risk Management for Device Manufacturers + United States FDA Pre-Market and Post-Market Product Cybersecurity Guidance's + European Commission's Guidance… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Coordinate, prepare, and complete premarket applications to the US FDA including Premarket Notification [510(k)] and Pre/Q-Sub submissions in a timely ... manner. Act as liaison with FDA regarding product submissions. + Assess US regulatory requirements...and completion of 510(k) submissions. + Experience collaborating with FDA personnel during 510(k) review and meetings with the… more
- ThermoFisher Scientific (Fremont, CA)
- …and production and laboratory standards are in compliance with all GMP, ISO, FDA , OSHA and other company manufacturing and safety guidelines. Ensures quality systems ... are effectively maintained to achieve strong levels of GMP/ISO/ FDA /OSHA compliance . Responsible for meeting financial targets, key measurements and benchmarks… more