- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- Abbott (Santa Clara, CA)
- …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,...+ In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485, GDPR) relevant to software products,… more
- Abbott (Santa Clara, CA)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Terumo Neuro (Aliso Viejo, CA)
- …approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy...Strong technical writing skills as evidenced by successful US FDA Class II / III medical device submissions, EU… more
- Medtronic (Irvine, CA)
- …and author new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Excellent communication & organizing skills + Knowledge of FDA , EU, and TGA requirements + Knowledge of Neurovascular… more
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …Preferred Qualifications: * Experience working with radiopharmaceuticals and knowledge of FDA regulatory pathways. * ACRP certification, expertise in ... Preferred qualifications * Experience working with radiopharmaceuticals and knowledge of FDA regulatory pathways. * ACRP certification, expertise in … more
- Sumitomo Pharma (Sacramento, CA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Kelly Services (Valencia, CA)
- … regulatory programs across two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product ... + Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +...or more of FDA submissions and international regulatory compliance. + Lead Auditor certification preferred. + Strong… more
- Robert Half Finance & Accounting (Oakland, CA)
- …optimization opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance. This is a hands-on role in an ... + Monitor the cost impact of design or process changes associated with FDA approval cycles or regulatory requirements. Continuous Improvement: + Evaluate the… more