- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a ... medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards,… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro ... **Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a… more
- Abbott (Alameda, CA)
- …Software as a Medical Device (SaMD) in a regulated environment. + Regulatory Strategy: Develop and execute global regulatory strategies and roadmaps for ... and EU MDR/IVDR. + Successful track record of preparing and submitting regulatory dossiers for medical devices, particularly SaMD, in various international… more
- Abbott (Alameda, CA)
- …skills to propose strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD ... medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific… more
- J&J Family of Companies (Santa Clara, CA)
- …Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining ... experience in medical device, life science, pharma industry Experience in regulatory affairs is preferred + Highly proficient with MS Word, SharePoint (or… more
- Sumitomo Pharma (Sacramento, CA)
- …communication + Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements + ... requirements cross functionally through comprehensive education initiatives + Oversees Regulatory operation and medical writhing team as appropriately +… more
- Sanofi Group (San Diego, CA)
- …engagement with cross-functional teams to achieve shared goals, including commercial, medical , and regulatory colleagues + Robust network development abilities, ... **Job Title:** T1D Immunology Medical Science Liaison, San Diego-LA WN **Location:** US...Stay updated on emerging scientific and technological advances and regulatory requirements in T1D immunology to inform strategic decision-making.… more
- BeOne Medicines (San Mateo, CA)
- …execution, communication and influence with internal stakeholders (eg, clinical development, medical , regulatory , labeling) and external stakeholders (eg FDA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more
- US Tech Solutions (San Bruno, CA)
- …Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified Bodies, ... and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical ...and regulatory submissions. + Support bringing novel medical devices from concept to release, manage project schedules,… more
- Cardinal Health (Sacramento, CA)
- … medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more