- Stryker (Fremont, CA)
- …artwork, design verification, shelf life testing, label design, and support regulatory submissions. To learn more about Stryker's Neurovascular portfolio visit: ... of Customer insights. + Collaborate cross-functionally with quality, manufacturing, regulatory , clinical, marketing, R&D device designers, supply chain, vendors, and… more
- Ascendis Pharma (Palo Alto, CA)
- …create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the ... SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations. + Responsible for identifying and developing training… more
- Ascendis Pharma (Palo Alto, CA)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Bausch + Lomb (Sacramento, CA)
- …departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety, ... manage and monitor study related expenses to meet forecast. Regulatory Reports: + Provide Clinical Operations support in the...including:** + Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date + 401K Plan… more
- Wells Fargo (Corte Madera, CA)
- …training, military experience, education + US only: Successfully completed Financial Industry Regulatory Authority (FINRA) Series 7 and 63 or 7 and 66 examinations ... model + Knowledge and understanding of branch exams and regulatory requirements from an operational support perspective + Strong...+ Paid time off + Disability benefits + Life insurance , critical illness insurance , and accident … more
- J&J Family of Companies (Irvine, CA)
- …and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing ... to ensure adherence to business plans; . Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and … more
- Merck (Sacramento, CA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end diagnostic strategy in… more
- AECOM (Fresno, CA)
- …documentation, oversees issue resolution, supports permit amendments, and coordinates with regulatory agencies. This is a dynamic position that blends project ... management with construction compliance experience and deep regulatory knowledge-an opportunity to work at the intersection of construction, environmental planning,… more
- AbbVie (Irvine, CA)
- …advance medicines to our patients. Responsibilities: + Provide expertise/lead regulatory submission and product life-cycle management strategy planning and ... drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety, or GMA) to create development strategies for assigned… more
- Kelly Services (South San Francisco, CA)
- …of CMC, you'll be instrumental in overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success. ... oligonucleotide drug substances, supporting clinical and eventual commercial launches. + Regulatory Contribution: Author and review IND/IMPD and other relevant … more