- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Preferred… more
- Alameda Health System (Oakland, CA)
- …Imaging in interdepartmental initiatives involving IT, Quality, Education, Compliance, and Regulatory Affairs . **DUTIES & ESSENTIAL JOB FUNCTIONS:** NOTE: The ... strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS workflow support, and radiologic student training… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director , Head, ICSR ... create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Abbott (Alameda, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Associate Director , Complaint Handling** **Working at Abbott** At Abbott, you ... Qualifications** + Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs or a related field or equivalent combination of education and… more
- Grifols Shared Services North America, Inc (Oakland, CA)
- …for the therapeutic area(s). + Partners with the Medical Directors, National MSL Sr Director , and North America Medical Affairs Sr Director to develop ... and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a...of field medical plans, strategy, and activities within Medical Affairs , as aligned with goals and objectives. This position… more
- Ascendis Pharma (Palo Alto, CA)
- …clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , health economics ... and solve complex drug development problems + Contribute to regulatory strategy + Contribute to drafting and reviewing of...Those with less experience may be considered for an Associate Medical Director position. + At least… more
