- Cardinal Health (Sacramento, CA)
- **_What Regulatory contributes to Cardinal Health_** Legal provides the company with strategic, proactive, practical and cost-effective legal advice and services in ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- Ascendis Pharma (Palo Alto, CA)
- … drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Specialist** is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory ... Certificate of Foreign Government and Certificates of Free Sale + Resolve regulatory issues and ensure companywide compliance. + Reviews regulatory publications… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening ... respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory… more
- Meta (Burlingame, CA)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical ... wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or… more
- Abbott (Santa Clara, CA)
- …products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters, ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs ... are as follows: **Responsibilities:** + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory… more
- Abbott (Santa Clara, CA)
- …products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters, ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our… more
- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory ... staff contracted to publish and dispatch health authority submissions. + Represents Regulatory Operations on project teams for matters relating to electronic (and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, ... and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively collaborates… more