- Hologic (San Diego, CA)
- … Quality Sr. Director / Director that may affect product quality or regulatory compliance . + **Interdepartmental Collaboration:** Work with other ... auditing program, ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead...Performance Indicators. + **Support Leadership:** Assist the Global Supplier Quality Sr. Director / Director as needed.… more
- Abbott (Santa Clara, CA)
- …business units that Leveraged Services team supports. **The Opportunity** The **Associate Director Regulatory Affairs** will work for our Global Regulatory ... Administration (FDA) Center for Devices and Radiological Health (CDRH). This Associate Director Regulatory Affairs may analyze broad scope implications of… more
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...regulatory requirements to development teams. + Manage preapproval compliance activities. + Formulate company procedures to respond to… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Devices and Combination Products works with ... audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations, and regulatory guidance as… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures + Establishes organization ... Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking ...business needs, drive timelines for global submission/clearance targets, including compliance , and effectively manage the RA team to ensure… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the ... both internally and with external partners. + Collaborate with Regulatory Affairs, Clinical, CMC, Quality , Safety, and...SDLC methodologies and CFR Part 11 and Annex 11 compliance . + Knowledge of drug development and submission requirements… more
- Merck (Sacramento, CA)
- **Job Description** We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal ... Quality Management, Quality Management Systems (QMS), Quality Operations, Regulatory Compliance , Regulatory Inspections **Preferred Skills:**… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …years' relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more