- Kelly Services (Alameda, CA)
- ** Regulatory Affairs Policy, Intel, & Compliance Director ** + Direct Hire + Location: Alameda, CA or King of Prussia, PA + The base pay range: $183,000 - ... quality procedures. + Establish process and measures to ensure Regulatory Affairs compliance with ...Establish process and measures to ensure Regulatory Affairs compliance with regulatory requirements.… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...Develop and advance the organizations policy and procedures for regulatory affairs and compliance to… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... area or law is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo… more
- Kelly Services (Alameda, CA)
- …managing communication between teams and ensuring compliance with global regulatory standards. The Director will foster cross-functional partnerships to ... ** Director of Scientific Affairs - Bay...planning, audit frequency, and tracking of findings to ensure regulatory compliance . + Lead inspection readiness activities,… more
- Abbott (Pleasanton, CA)
- …constituencies, Global Marketing, Sales, R&D, Complaint Handling, Technical Support, Clinical Affairs , Regulatory Affairs , Legal, international geographies ... on with their lives. Abbott HF is seeking a Director of Global Education to be based at our...(clinicians) training programs that facilitate the learning, professional development, compliance with IFU's and best practices. The individual will… more
- CSL Plasma (Fairfield, CA)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job Description** + Serves… more
- BeiGene (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... developmental and approved BeiGene products + Actively leads Development and Medical Affairs product teams in the identification of, and handling of product safety… more
- BeiGene (Emeryville, CA)
- …+ Pharmacovigilance + Clinical Business Operations + Biometrics + Medical Monitors + Regulatory Affairs + Interacts with all levels of BeiGene **Travel:** May ... **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is responsible for supporting and maintaining a proactive,… more
- BeiGene (Emeryville, CA)
- …+ Clinical Development + Clinical Business Operations + Biometrics + Medical Monitors + Regulatory Affairs + Interacts with all levels of BeiGene + BGNE ... **General Description:** The Director , GCP Inspection Management, is responsible for: +...inspection readiness, hosting and coordinating GCP inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS,… more
- BeiGene (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs . + Ensures regional and country information in study systems ... for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. + Provides regional input on global study… more
- BeiGene (Emeryville, CA)
- …for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. + Provides regional input on global study ... local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used...heads. + Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other… more
- Children's Hospital & Research Center Oakland (Oakland, CA)
- …the performance of care and services provided.** **Assure continual readiness for regulatory compliance .** **Maintain an environment that promotes patient safety ... The incumbent works collaboratively with the Medical Directors, the Executive Director of Ambulatory Care, other Practice Administrators, and the Vice President… more
- BeiGene (Emeryville, CA)
- …Collaborate with agency partners to develop core content package and ensure compliance with regulatory -legal-medical requirements. + Support the development of ... efforts. This role requires strong collaboration with the local markets and medical affairs to deliver an integrated launch plan. You will also be accountable for… more