- Meta (Burlingame, CA)
- …Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions 3. Provide expertise on regulatory requirements and ... guidance to internal stakeholders 5. Collaborate with Product Management, Engineering, Quality , and other teams to ensure product compliance throughout the lifecycle… more
- Medtronic (Santa Rosa, CA)
- …expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA ... influences the preparation of documentation to support innovative and high- quality regulatory submissions from early phase strategies, marketing applications, and… more
- Fujifilm (Sacramento, CA)
- …opinion leaders in the Endoscopy space. The role of the Business Development Manager is to understand and define our internal and external endoscopic customers' ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- University of Southern California (Los Angeles, CA)
- …data on patients hospitalized at other institutions. + Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) ... studies such as National Cancer Institute (NCI), Food and Drug Administration ( FDA ) and pharmaceutical audits. + Completes spreadsheets for industry studies in real… more
- Abbott (Sylmar, CA)
- …Work On** + Collaborate with site EHS team and enterprise environmental manager , handle and lead environmental compliance activities, programs and prevention efforts ... Support all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory… more
- Fujifilm (Sacramento, CA)
- …engineers. + Maintains a high level of success with yearly goals provided by your manager and metrics defined on a team level. + Working outside of normal business ... the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job… more
- Stryker (Sacramento, CA)
- …sales associated tasks, maintain strong, positive customer relationships, and to provide quality coverage in multiple territories across the country for employees on ... trade shows, conventions, and/or clinical meetings. + Keeps regional manager informed of territory progress on a regular basis....all GMP policies and procedures as stipulated by the FDA . QUALIFICATIONS: + Must be able to handle routine… more
- Danaher Corporation (Lodi, CA)
- …processes in our IVD Factory. This position reports to the Maintenance Engineering Manager and is part of the Engineering team located in Lodi, California and ... for continuous improvement of OEE and maintenance processes for compliance with Company, FDA , ISO, OSHA and GMP regulations. The essential requirements of the job… more
- CSL Plasma (Stockton, CA)
- …and following Standard Operating Procedures (SOPs). You will report to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the ... In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis...in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient… more