- Gilead Sciences, Inc. (Foster City, CA)
- …Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and ... regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma industry. ... Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Meta (Burlingame, CA)
- …approvals 2. Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions 3. Provide expertise on ... **Summary:** As a Regulatory Affairs Lead, you will play a key...to internal stakeholders 5. Collaborate with Product Management, Engineering, Quality , and other teams to ensure product compliance throughout… more
- Medtronic (Santa Rosa, CA)
- …and influences the preparation of documentation to support innovative and high- quality regulatory submissions from early phase strategies, marketing ... Affairs staff. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …content. Support regulatory impact assessments for change controls and other Regulatory Affairs/ Quality Assurance items from a review and approval level. + ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role...and existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive, EU… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager** will work on-site in Alameda, CA for our Diabetes ... people monitor their glucose levels with our new sensing technology. As the Regulatory Affairs Manager, you will combine your knowledge of scientific, legal and… more
- Stryker (San Jose, CA)
- …can be provided. **Key Areas of Responsibility:** + Ensure divisional achievement of quality , regulatory , and compliance targets + Direct activities to ensure ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements +… more
- J&J Family of Companies (Irvine, CA)
- …Degree is preferred. + A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is ... & Johnson is currently seeking a Senior Manager, Source Regulatory Compliance to join our Regulatory Compliance...They will engage with business partners, such as Supplier Quality & supplier relations and Suppliers. In addition, they… more
- Kelly Services (Irvine, CA)
- …+ _Ability to communicate effectively, both in writing and verball_ + _Familiarity with quality and regulatory systems including FDA 's Quality System ... The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide_ _As a Kelly employee, you… more