- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product ... + Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +...or more of FDA submissions and international regulatory compliance. + Lead Auditor certification preferred. + Strong… more
- Robert Half Finance & Accounting (Oakland, CA)
- …optimization opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance. This is a hands-on role in an ... + Monitor the cost impact of design or process changes associated with FDA approval cycles or regulatory requirements. Continuous Improvement: + Evaluate the… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within the ... personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents… more
- IQVIA (San Francisco, CA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strong relationships + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven ... experience preferred + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Computer… more
- Actalent (Vista, CA)
- …audits. + Manage customer product complaints and ensure timely resolution. + Oversee regulatory submissions including FDA 510(k), CE mark, and other product ... proper categorization and filing. + Serve as the primary liaison with FDA and other regulatory bodies. Qualifications + Bachelor's degree in a related field or… more
- Lilly (San Diego, CA)
- …and strategy ** Regulatory & Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning ... of regulatory requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies) + Familiarity with target… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... Software Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304). + Strong knowledge of risk… more
- Kelly Services (Pleasanton, CA)
- …site-specific documentation. + Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards. + Develop and manage the company's Master ... Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab. This role reports directly… more
- Cardinal Health (Sacramento, CA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more