- Curia (Camarillo, CA)
- …processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs . + Direct quality and compliance process improvements and ... for establishing and maintaining the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. This position's… more
- Astrix Technology (CA)
- …+ Quality Control, Quality Assurance, Quality Systems, Document Control + Regulatory Affairs + Laboratory Personnel (Chemists, Microbiologists, Lab Technicians, ... Lab Coordinators) + Process Development (Upstream or Downstream) + Manufacturing Associates + Project Coordinators & Project Managers + and more We are an equal opportunity employer and all qualified applicants will receive consideration for employment without… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Develop documentation per regulatory body guidelines. + Interface with internal regulatory affairs and assist with submissions. + Support of medical device ... company audits processes. + Understanding of electrical systems and reading schematics. + Debug/Troubleshoot complex systems and implement fixes. + Collaborate with HW Engineers to develop and implement design concepts. + Other duties as assigned.… more
- Abbott (Pleasanton, CA)
- …an exciting opportunity for the right candidate to join our Global Clinical and Regulatory Affairs team within the Heart Failure Division (HFD) as the **Director ... by collaborating closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Medical Affairs , Reimbursement) and external stakeholders (researchers,… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical Development to ensure ... as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. +...and drug product. + Proven track record in drafting regulatory documentation at all stages, including **IND, BLA, and… more
- Abbott (Pleasanton, CA)
- …information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …decision, as applicable. + Collaborates with leadership in Business Unit Quality, Regulatory Affairs , R&D, Operations, Service, Medical Affairs , Legal, ... creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the...ensuring that commitments made to the FDA and other regulatory agencies (eg, recall letters) are implemented at the… more
- Terumo Neuro (Aliso Viejo, CA)
- …Stakeholder Management + Collaborate closely with cross-functional teams, including R&D, regulatory affairs , manufacturing, quality assurance, and marketing, to ... desirable. 3. Strong knowledge of medical device development processes, regulatory requirements, and quality management systems. 4. Excellent analytical skills… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more