- Abbott (San Diego, CA)
- …local and territorial trade requirements, agreements and considerationsDomestic and international regulatory guidelines, policies and regulations Ethical ... also have access to: + Career development with an international company where you can grow the career you...executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego,… more
- Oura (San Francisco, CA)
- …+ Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals. + Proven track record of successful management of ... regulatory filings including 510(k)s, De Novo submissions, and international registrations. + Partner with science, data science, engineering, clinical,… more
- Edwards Lifesciences (Irvine, CA)
- …teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government ... and regulatory authorities, and alongside diverse internal stakeholders, your close...Biology, Microbiology, Chemistry) + Experience in preparing domestic and international product submissions + Full knowledge and understanding of… more
- Merck (San Diego, CA)
- …+ Experience with biologics or small molecules + Substantial experience in US & International Regulatory Affairs with prior experience as a Global Regulatory ... **Required Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance, Leadership, Motivation Management, Pharmaceutical… more
- Edwards Lifesciences (Irvine, CA)
- …teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government ... and regulatory authorities, and alongside diverse internal stakeholders, your close...years related experience + Experience in preparing domestic and international product submissions Aligning our overall business objectives with… more
- Edwards Lifesciences (Irvine, CA)
- …teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government ... and regulatory authorities, and alongside diverse internal stakeholders, your close...look for (Preferred):** + Experience in preparing domestic and international product submissions + Excellent written and verbal communication… more
- Kelly Services (San Fernando, CA)
- …maintain compliance records + Assess supplier documents and product formulations for international regulatory compliance + Maintain compliance database + Prepare ... ** Regulatory Affairs Specialist III - San Fernando, CA**...Halal, Kosher, and Organic certification processes + Familiarity with international regulations is preferred + Strong logic, reasoning, and… more
- Kelly Services (Valencia, CA)
- …+ Proven experience with 5 years or more of FDA submissions and international regulatory compliance. + Lead Auditor certification preferred. + Strong ... leading client. In this role, you'll ensure compliance with FDA, ISO, and international regulations and submissions while managing regulatory programs across two… more
- Medtronic (Irvine, CA)
- …new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct + ... 4 years of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling, or an… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …clinical Decision Support Software Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304). ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of product clearances and maintain the… more