and identify opportunities for improvement through automation. Sourcing/co-developing solutions with strategic vendors, doing R... related compliance requirements and safety standards. Ex: OSHA, CE, ANSI, ISO, IEC. Primary Work location: This position...
marketing, R&D, clinical, regulatory, and operations, to deliver quality, compliant products. Oversee risk management using... of experience working in a highly regulated industry in the areas of Research & Development (R&D), Quality (QA/QC), Software...
pharmacies, and human drug outsourcing compounding facilities. The lab is DEA and FDA registered, cGMP certified, and ISO/IEC... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
and onsite to experiment, discover, create, and simply connect with others toward a common purpose. R&D engineers... in San Diego or Brea, CA. Job Responsibilities: Lead R&D deliverables throughout the medical device design control...
under standards such as ISO 9001, ISO 13485, and ISO/IEC 17025. Market Engagement & Thought Leadership: Develop compelling product..., ISO/IEC 17025) relevant to product development and quality assurance. Demonstrated ability to translate technical...
, and human drug outsourcing compounding facilities. The lab is DEA and FDA registered, cGMP certified, and ISO/IEC 17025:2017... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
under standards such as ISO 9001, ISO 13485, and ISO/IEC 17025. Market Engagement & Thought Leadership: Develop compelling product..., ISO/IEC 17025) relevant to product development and quality assurance. Demonstrated ability to translate technical...
Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards.... Partner with R&D and Systems Engineering to ensure design inputs and outputs are clearly defined, traceable, and verifiable...
Job Category: R & D Job Description: Lead development and validation of new product designs from concept to full... projects. Advanced knowledge of regulatory standards (ANSI, IEEE, IEC) Demonstrated verbal and written communication skills...
13485, and other relevant regulatory standards. Collaborate with cross-functional teams including R&D, Regulatory... standards (ISO 14971) and usability engineering (IEC 62366). Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part...