- Oura (San Francisco, CA)
- …work - both in and out of the office. We are looking for a Director , Regulatory Affairs and Quality Assurance to play a key role in shaping Oura's future ... products and services. What you will do: + Lead regulatory and quality strategy for product development,...you have: + Bachelor's degree in life sciences, engineering, regulatory affairs , or a related field; advanced… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... important new medicines for devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate… more
- Caldera Medical (Westlake Village, CA)
- Director of Regulatory Affairs ONSITE in Westlake Village, CA Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the ... Hiring Manager: The Director of Regulatory Affairs will...and integrate into internal processes. * Collaborate with R&D, Quality , Clinical, and Marketing teams to align regulatory… more
- Actalent (Valencia, CA)
- Job Title: Director of Regulatory AffairsJob Description The Director of Regulatory Affairs leads the development and execution of global ... timelines. + Supervise, mentor, and develop a team of regulatory affairs professionals. + Assign responsibilities, manage...with MDSAP, IEC, and ISO standards. + Knowledge of quality management systems and regulatory intelligence tools.… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our ... the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs ,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
- United Therapeutics (Sacramento, CA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ ... biologic or pharma regulatory experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area of study or 7+ years of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises....Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
- BeOne Medicines (Emeryville, CA)
- …or biopharmaceutical industry experience in innovative drug CMC development, manufacturing, Quality , etc. including minimum 8 years of regulatory CMC ... device is a plus. * In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP regulation… more
- Stryker (San Jose, CA)
- **Key Areas of Responsibility:** + Ensure divisional achievement of quality , regulatory , and compliance targets + Direct activities to ensure new product ... a multi-discipline, multi-technology, team-based organization and assume responsibility of quality , regulatory , and compliance targets + Demonstrated ability… more