- Terumo Neuro (Aliso Viejo, CA)
- …in a relevant field (neurology, neuroradiology, or neurosurgery). 3. Knowledge of GCP, FDA , and ICH regulations and guidelines. 4. Knowledge and experience in the ... detection, understanding, review, investigation, and assessment of adverse events. 5. Class III medical device safety experience. **External-Facing Title:** Specialist, Clinical Safety **Posting Country:** US - United States **Salary Range:** $85,000-$115,000… more
- Amgen (Thousand Oaks, CA)
- …priorities in a very dynamic environment + Experience in project management and FDA type Quality Management Systems + Ability to lead projects independently and take ... ownership and accountability of assigned tasks + Excellent written and verbal communication skills, along with a demonstrated ability to work in a team environment + Familiarity with the following programs/software: SAP Arriba, Trackwise, Minitab, MS Office… more
- Cordis (Irvine, CA)
- …(Coronary)** role is a key position within the coronary program to help ensure FDA clearance through a PMA approval of this innovative device is granted and patients ... have access to this device. In this role, you will be participating in a clinical study team in the coronary space to execute a randomized, multi-center IDE clinical trial. You will perform various duties and responsibilities as directed by the clinical study… more
- Danaher Corporation (Brea, CA)
- …in: + Experience with healthcare regulation, including: fraud and abuse (eg, anti-kickback); FDA for medical devices; data use and privacy (eg, HIPAA, GDPR); and ... anti-corruption (eg, FCPA) + Experience with software transactions The salary range for this role is $160,000-$190,000 annually. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.… more
- ThermoFisher Scientific (Pleasanton, CA)
- …Standards such as ISO 13485 and ISO 9001. + Experience with FDA /regulated products, preferred BENEFITS: We offer competitive remuneration, annual incentive plan ... bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …with new and existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility ... Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary. Drive continuous improvement in internal processes and customer satisfaction. + Support the monitoring and interpretation of current and new… more
- Terumo Medical Corporation (San Francisco, CA)
- …new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumos policies at all times. Perform ... other job-related duties as assigned. **Job Responsibilities (continued)** **Working Conditions/Physical Requirements** + This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive long… more
- Abbott (Alameda, CA)
- …with system identification/stochastic modeling and algorithm development for sensor systems through FDA clearance or approval. **Preferred** + A master's degree or a ... PhD is ideal. + Experience in the medical device space, ideally within diabetes or other metabolic diseases. + Experience creating mathematical models of biological dynamics &/ electrochemical systems by reconciling clinical data and first principles by system… more
- Oura (San Francisco, CA)
- …related to women's health or wellness (strongly preferred). + Experience with FDA -regulated products or other regulated health industries. + Experience with wearable ... devices and/or machine learning algorithms. + Experience with complex projects that involve mobile, backend, data science, firmware and QA, while also acting as the team's point of contact for release management to ensure timely production deployments. +… more
- Barry Callebaut (American Canyon, CA)
- …accountability, and teamwork. Regulatory Compliance * Ensure compliance with OSHA, FDA , USDA, EPA, and other regulatory bodies. * Participate in internal ... and external audits, inspections, and certification processes. * Maintain updated records of cleaning activities, chemical usage, and validations. Quality Control & Inspections * Conduct regular inspections of production lines, equipment, and common areas. *… more