- Abbott (Alameda, CA)
- … specialists + Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. + Represent ... approval requirements + Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide regulatory … more
- Abbott (Santa Clara, CA)
- …regulated industry (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- Abbott (Temecula, CA)
- …and research/select new tools based on findings. + Ensures sustaining support of Quality System and regulatory compliance by individually working ... external firms or agencies. + Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (eg compliance with internal… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... content product and process changes, and product documentation to assure regulatory requirement's compliance , consistency, and accuracy + Other incidental… more
- Terumo Neuro (Aliso Viejo, CA)
- …product lines per MicroVention procedures. + Review promotional material and labeling for regulatory compliance as assigned. + Develop and maintain regulatory ... for worldwide product approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for… more
- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... for diversity, working mothers, female executives, and scientists. In Abbott's Global Regulatory Services (GRS) division, we're helping people to have access our… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with ... regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global… more
- Stanford University (Stanford, CA)
- …strong team of regulatory experts responsible for the administration and regulatory compliance of clinical research within the university, and represent the ... communication skills, teamwork, and superb attention to detail. We strive for top- quality regulatory support of investigator-initiated clinical trials with a… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …requirements. + Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . Assist in the collection of regulatory ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more