- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II - APAC** will work ... team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues,… more
- Abbott (Pleasanton, CA)
- …a best place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist ** ** II ** will work out of ... + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a...in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a plus. Apply Now… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Materials & Reagents Center of Excellence, Quality Compliance, Supply Chain, and Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls). This person ... experienced professional will provide product quality support that focuses on regulatory writing of BLA sections for Kite's fast-moving clinical programs. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are ... a wide variety of activities to ensure compliance with applicable regulatory requirements. + Participates in developing Standard Operating Procedures (SOPs) to… more
- Medtronic (Northridge, CA)
- …90,000+ employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist , you will develop and implement medical device ... external networks. In this role, you will have primary RA responsibility for multiple Class II (IIa/IIb)... agencies. + As an individual contributor, the Principal Regulatory Affairs Specialist is responsible… more
- Edwards Lifesciences (Irvine, CA)
- …maintaining regular, in-person collaboration. **How you'll make an impact:** As a Senior Specialist , Regulatory Affairs , you work with other functional areas ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...understanding of domestic and global regulations relevant to Class II and/or Class III medical devices Aligning our overall… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to...Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus.… more
- Actalent (Laguna Hills, CA)
- Description: This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device industry and ... have Class II or Class III device experience. Candidate will: Prepare...maintain Adagio compliance. Post-market and vigilance reporting process. Represent Regulatory Affairs on Engineering & R&D product… more
- Edwards Lifesciences (Irvine, CA)
- …and be part of our inspiring journey. **How you will make an impact:** As a Specialist , Regulatory Affairs for TMTT, you will complete and maintain clinical ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...understanding of global regulations relevant to medical devices, Class II and/or Class III + Solid knowledge of global… more
- Abbott (Alameda, CA)
- …help Abbott shape the future of healthcare. As an individual contributor, the **Senior Regulatory Affairs Specialist ** will support product development and ... opportunity at Lingo. **What You'll Work On** + Represent Regulatory Affairs on cross functional project teams...input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical… more
- Edwards Lifesciences (Irvine, CA)
- …regular, in-person collaboration. **How you'll make an impact:** As a Senior Specialist , International Regulatory Affairs , you complete and maintain ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Full knowledge and… more
- Amazon (Sunnyvale, CA)
- …Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in ... in a regulated industry with experience working with Class II and/or Class III devices. - . Ability to...dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug… more
- Edwards Lifesciences (CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...EU and US regulations relevant to medical devices, Class II and/or Class III devices * Full knowledge and… more