- Globus Medical, Inc. (San Diego, CA)
- …in full compliance with Globus quality system and other applicable regulatory bodies + Design and develop instruments and implants using Pro/E software + ... and market plans + Assist in the writing of regulatory applications to the FDA and other...Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both… more
- Cedars-Sinai (Los Angeles, CA)
- …needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and ... implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report… more
- Danaher Corporation (Sunnyvale, CA)
- … compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union ... requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities + Provide cross-functional compliance support for… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …their reports. **Responsibilities:** + Lead and develop direct report associates to ensure regulatory compliance + Problem solve and escalate regulatory and ... a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director of...effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal for someone who ... to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal...conferences and scientific meetings. + Represent BDB externally with regulatory agencies, notified bodies, FDA , etc. +… more
- Kelly Services (Pleasanton, CA)
- …documentation. + Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards. + Develop and manage the company's Master Schedule. ... and administer a company Risk Register. + Identify and address regulatory compliance issues, providing guidance to other departments. + Deliver monthly … more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …process discipline required in a Class 1 and Class II FDA -regulated manufacturing environment. Their organizational, communication, and leadership skills are second ... and budget targets + Adhere to and meet all regulatory requirements + Coach, lead and create a culture...+ Work within the company's corporate quality system and ISO/ FDA regulations to remain compliant. + Develop and manage… more
- Stryker (San Jose, CA)
- …improvement across the software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and ... Google, Microsoft, or similar, demonstrating strong technical skills + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820,… more
- Cedars-Sinai (Los Angeles, CA)
- …research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties...visits and procedures; ensure smooth coordination. + Assist with regulatory submissions to the Institutional Review Board (IRB), including… more
- Danaher Corporation (Sunnyvale, CA)
- … compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union ... implement improvements. This position reports to the Senior Manager Quality Systems - Compliance and is part of the Quality Systems department located in Sunnyvale,… more