- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... a week 4. Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA /ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and ... Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (eg, deviations, CAPA, change control, complaints) in a regulated… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …reports. + Ensure compliance with design control procedures, medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485), and company policies. + Contribute to ... actions. Compliance & Audits: + Support internal and external audits (eg, FDA , ISO) by providing documentation and technical expertise related to design quality.… more
- Danaher Corporation (San Diego, CA)
- …including user guides, service guides, and instructions that strictly adhere to FDA , EU MDR/IVDR, and ISO 13485 requirements, ensuring all materials are audit-ready. ... + Strong working knowledge of medical device regulations and quality standards, including FDA (21 CFR Part 820), EU IVDR/MDR, and ISO 13485. + Demonstrated expertise… more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more
- IQVIA (San Francisco, CA)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Oncology is preferred. **Essential ... given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.)_** **Qualifications** + MD Degree required. + 15+… more
- Astrix Technology (Los Angeles, CA)
- …2 years management experience. Experience drafting & rewriting SOPs, audits, FDA filings/docs, CAPAs, change controls, batch records, documentation. Knowledge of ISO ... 22716 & FDA regulations INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race,… more
- Stryker (San Jose, CA)
- …+ Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems. + Promote a customer-centric quality ... Management, and Supplier Quality. + Familiarity with ISO 13485, ISO 14971, and FDA regulations. + Excellent communication and leadership skills; ability to train and… more
- Imperative Care (Campbell, CA)
- …methods (DOE, SPC) with proficiency in Excel and Minitab. + Solid knowledge of FDA Design Control, DFSS/DFM tools, GMP/GDP, and relevant standards (ISO 13485, FDA ... QSR). + Excellent critical thinking - able to connect cause and effect, prioritize under constraints, and deliver practical solutions. + Experience in pilot and production line setup, validation, and scale-up. + Proven ability to work independently and to… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and validation activities, ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more