- Meta (Burlingame, CA)
- …projects/products at reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site ... We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical… more
- Medtronic (Santa Rosa, CA)
- …Affairs staff. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, ... work together to engineer the extraordinary. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and their… more
- Kelly Services (Anaheim, CA)
- …products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing ... complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with...USA and global regulations. + Proven experience interfacing with regulatory bodies such as FDA , Notified Bodies,… more
- Meta (Burlingame, CA)
- … Regulatory Affairs Lead, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized in ... approvals 2. Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions 3. Provide expertise on… more
- J&J Family of Companies (Santa Clara, CA)
- …Raritan, NJ; West Chester, PA; Irvine, CA; or Danvers, MA. **Purpose:** The Healthcare Compliance Manager will support Shockwave Medical, and play a key role in ... We are searching for the best talent for a ** Manager , Health Care Compliance ** to be based...ensuring the Company meets statutory and regulatory requirements relating the health care fraud and abuse;… more
- Gilead Sciences, Inc. (Foster City, CA)
- …candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch ... design SAP BRH solutions that optimize batch release processes. ** Regulatory Compliance :** + Ensure that all SAP...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. +… more
- Stanford Health Care (Palo Alto, CA)
- …staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, sample ... Managers and clinic staff on pharmacy-related issues such as regulatory changes/ compliance , FDA drug recalls,...storage areas on-site and remote sites. + Responds to manager inquiries related to compliance issues. **Education… more
- Biomat USA, Inc. (Upland, CA)
- …team, responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role ... medicines, solutions and services in more than 110 countries and regions. **Acknowledgment** : The Operations Manager is a key member of the donor center leadership… more
- Terumo Neuro (Aliso Viejo, CA)
- …consistent. + Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other ... **12521BR** **Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior...clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs… more
- Kelly Services (Sacramento, CA)
- … with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will lead a team in managing ... and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance . + Assist in the development or assignment of… more