- Element Materials Technology (Morgan Hill, CA)
- …testing and certification services for wireless products + Ensure compliance with international regulatory standards, including FCC, CE (RED/EMCD), IC, and other ... products. The successful candidate will play a key leadership role, leveraging regulatory experience to guide technical teams, ensure regulatory alignment, and… more
- J&J Family of Companies (Irvine, CA)
- …and pre-sale/post-installation engagements. + Represent product security in FDA and international regulatory inspections, reinforcing trust in our devices. + ... of J&J MedTech. The ideal candidate is a hands-on technical leader with regulatory and commercial awareness, able to simplify complex security topics to various… 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
- 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
- Crane Aerospace & Electronics (Los Angeles, CA)
- …and its development, documentation, and implementation with respect to domestic and international regulatory standards or requirements. + Must have basic to ... to interpret engineering drawings, test procedures, work orders, BOMs, written procedures, international standards, etc. + Must be able to analyze, interpret, and… 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 ... Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake Village,...MDR 2017/745, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other international medical device regulations. * Proven experience in preparing… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC ... actions taken, aligned with BD's quality systems and ensuring compliance with regulatory standards and practices. + Lead remediation efforts for updating risk… more
- Cathay Pacific Airways Limited (San Francisco, CA)
- …Good understanding of Company policies and procedures and all required local and international regulatory procedures + Ability to work diligently in fast-paced ... ensure lounge operations, employees and suppliers are fully compliant with all regulatory requirements and quality standards + Support local airport management to… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …of quality engineering processes and/or systems + Expert knowledge of domestic and international regulatory requirements (eg, FDA, GMPs, and ISO/EN standards) + ... Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing + Demonstrated ability to direct teams and provide coaching and… more
- AbbVie (Irvine, CA)
- …(QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies. Additional Information ... All your information will be kept confidential according to EEO guidelines. Salary: $35,000 - $172,500 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal… more