- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in Alameda, CA for our Diabetes ... glucose levels with our new sensing technology. As the Regulatory Affairs Manager, you will combine your knowledge of...8+ years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II, and… more
- J&J Family of Companies (Irvine, CA)
- …**Job Description:** Johnson & Johnson is currently seeking a Senior Manager, Source Regulatory Compliance to join our Regulatory Compliance team located in ... + Will establish, manage, maintain, and continuously improve Source Regulatory Compliance activities associated with assigned business Suppliers, including but… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Primary** **Responsibilities:** + Support regulatory effort to comply with new and existing regulations (eg, FDA ... Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive continuous improvement in… more
- Caldera Medical (Westlake Village, CA)
- …managing Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA , ISO, and other applicable regulatory requirements. The ideal candidate ... to investigation and closure, in accordance with internal SOPs and regulatory requirements. * Ensure timely and accurate complaint evaluations, including medical… more
- Meta (Burlingame, CA)
- …a related role 8. Understanding and implementation of verification activities based on regulatory requirements (eg, FDA , EU MDR, ISO 13485) and industry ... developing, implementing, and executing verification plans to ensure our products meet regulatory requirements and are safe and effective for users.You will work on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …comparator drugs and other co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance documents such as CFR, Annex ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Mentor Technical Group (South San Francisco, CA)
- …activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Bausch Health (Los Angeles, CA)
- …ethic to include; + Maintaining compliance with all applicable quality and regulatory guidelines including FDA and corporate guidelines. + Supporting company ... consumables or medical products to plastic surgeons or dermatologists in a FDA regulated, highly controlled environment. + Ideal candidates will also have knowledge… more
- Fortive Corporation (Irvine, CA)
- …the development and assessment of new technologies for potential products following the regulatory guidelines / standards ( FDA , TGA, ISO, EU MDR etc.). Ensures ... preferred. Professional experience in a GxP-regulated industry and understanding of QSR, FDA , and ISO guidelines is preferred. Working experience with sterilants and… more
- UCLA Health (Los Angeles, CA)
- …a Regulator Coordinator. In this role you will be responsible for regulatory coordination of clinical research studies within assigned units, departments or ... utilizes that information to prepare, manage and submit all required study / regulatory documents and all required applications and forms related to internal UCLA… more