- Danaher Corporation (Sunnyvale, CA)
- …+ Regulatory Knowledge & Submission ExperienceDeep understanding of FDA and international regulatory requirements (eg, IEC 62366, FDA HF Guidance) for ... to lead cross-functional teams and influence stakeholders across R&D, Clinical, Regulatory , Quality, and Marketing. Must be capable of championing user-centered… more
- General Atomics (San Diego, CA)
- …252.204-7016 through 7020, and Cybersecurity Maturity Model Certification (CMMC). + International regulatory requirements that affect that Aerospace and Defense ... continuous learning with a passion to keep abreast of changes in regulatory and technology environments. + Responsible for observing all laws, regulations, and… more
- Kelly Services (Burbank, CA)
- …industries. + **Technical Knowledge:** Understanding of CTFA/PCPC, AOAC, and international regulatory standards (EU, US, Japanese Pharmacopeias). **Skills** ... to 8-week project. If you have experience in microbial testing and regulatory compliance in pharmaceutical, cosmetic, or nutritional industries, trust The Experts at… more
- Amgen (Thousand Oaks, CA)
- …of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements + Ability to effectively present ideas and ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- Edwards Lifesciences (Irvine, CA)
- …of quality engineering processes and/or systems * Expert knowledge of domestic and international regulatory requirements (eg, FDA, GMPs, and ISO/EN standards) * ... practices while ensuring a culture of quality and compliance with global regulatory requirements. **How you will make an impact:** * Manage project activities… more
- BeOne Medicines (San Mateo, CA)
- …of quality throughout the enterprise. This role ensures QMS processes are aligned with international regulatory standards (eg, FDA, EMA, ISO 13485, ICH Q10 / E6) ... process knowledge and capabilities. + Represent your process areas during regulatory audits, inspections, and management reviews. + Identify and drive opportunities… more
- Imperative Care (Campbell, CA)
- …objectives. + Lead the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA, CE marking, etc.). + Build and ... sustain relationships with cross-functional peers in R&D, Clinical, Engineering, and Regulatory bodies. + Champion quality engineering principles and foster a… more
- Abbott (San Diego, CA)
- …medical risk management. + Interact with internal compliance organizations, FDA, and international regulatory bodies as needed to address product performance ... live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify… more
- Caldera Medical (Westlake Village, CA)
- …product submissions, modifications, and renewals to ensure compliance with local and international regulations. * Assist with defining the regulatory strategy ... Senior Regulatory Specialist Located in Westlake Village, CA; Onsite...MDR 2017/745, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other international medical device regulations. * Proven experience in preparing… more
- AbbVie (San Francisco, CA)
- …(QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Allergan complies. Additional ... trade shows/meetings + Maintaining compliance with all applicable quality and regulatory guidelines as an integral part of business operations. + Maintain… more
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