- Stanford Health Care (Palo Alto, CA)
- …clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs, sample medications, ... levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques of personnel… more
- US Tech Solutions (San Bruno, CA)
- …and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory audits. + Performing product qualification ... of work. + Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products incorporating hardware, firmware and… more
- Edwards Lifesciences (Irvine, CA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR, Japan PMDA, China NMPA) regulations. + Experience working in a cross functional, collaborative environment… more
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices ... with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485. **Tool Proficiency:** 1. Demonstrated ability to… more
- Terumo Neuro (Aliso Viejo, CA)
- …Supports preparation and hosting activities for third party audits including FDA , Notified Body, corporate and international regulatory authorities' audits. Supports ... multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices. 4. Demonstrates… more
- Abbott (Sylmar, CA)
- …and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing ... regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Grifols Shared Services North America, Inc (Bakersfield, CA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more
- Insight Global (Irvine, CA)
- …is required - Prior experience in the medical device industry or an FDA regulated industry preferred. - Excellent written, oral and presentation skills required ... (advanced Word, Outlook, and PowerPoint). - Strong analytic skills (Intermediate Excel). - Strong leadership skills and can work independently with minimal direction - Ability to work in a team environment and manage conflicting priorities - Ability to… more
- Genentech (South San Francisco, CA)
- …medical writing, and data analysis, with a thorough understanding of US regulatory/ FDA requirements. + Demonstrated ability to coach, mentor, and develop leaders, ... and to build relationships with and identify the needs of patients, providers, and payers. + Substantive understanding of corporate legal and compliance, including GCP, OIG, and other guiding elements of the business. + Proven track record of collaborating,… more
- Sutter Health (Sacramento, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ), and United States Pharmacopeia (USP). + Possess written and verbal ... communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. + General knowledge of computer applications, such as Microsoft Office Suite (Word, Excel and Outlook), related pharmaceutical… more