- Twist BioScience (South San Francisco, CA)
- …software architecture, and user manuals.Ensure software complies with applicable regulatory standards (eg, FDA , ISO 13485, if applicable).Contribute ... to research and development efforts for next-generation instruments.Evaluate new technologies, frameworks, and methodologies to improve instrument performance and usability.Work closely with scientists, lab personnel, manufacturing teams, and field service… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups… more
- Insmed Incorporated (San Diego, CA)
- …management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... budgets and forecasts.Experience leading cross-functional teamsExperience supporting audits or regulatory inspections.Experience with Veeva QualityDocs /QMS and understanding of… more
- Eisai, Inc (Los Angeles, CA)
- …of NASs and then leading demand generation in a manner consistent with the FDA -approved indication to meet or exceed sales objectives. This will be accomplished by ... conveying complex clinical information to customers and key stakeholders regarding FDA -approved indications of this novel therapy. The individual will implement and… more
- Eisai, Inc (San Jose, CA)
- …clinical information to customers and key stakeholders consistent with the FDA -approved indication. Additionally, the NAS will be responsible for ensuring customers ... sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating matrixed environments in a constructive… more
- Actalent (Lake Forest, CA)
- …for New Product Development and sustaining engineering projects - Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified ... - Strong understanding of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new...regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering,… more
- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Medtronic (Santa Rosa, CA)
- …negotiate submission issues with agency personnel. + Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products. + ... Product development experience + Clinical or statistical experience + Experience with FDA and international regulatory agency requirements, ISO/GHTF standards +… more
- ThermoFisher Scientific (Carlsbad, CA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada,… more
- Abbott (Pleasanton, CA)
- …for regulatory approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, company policies,… more
