- Medtronic (Irvine, CA)
- …new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct ... 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …(eg, FDA Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive ... RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs/ Compliance experience in medical devices + Experience with end-to-end SAMD new… more
- Stryker (San Jose, CA)
- …be provided. **Key Areas of Responsibility:** + Ensure divisional achievement of quality, regulatory , and compliance targets + Direct activities to ensure new ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements +… more
- UCLA Health (Los Angeles, CA)
- …the appropriate regulatory documents in a timely manner and in compliance with federal, state, and university mandated laws, regulations and policies. Pay Range: ... Surgery is seeking to hire a full time Research Compliance Analyst II to serve as a Regulator Coordinator....Coordinator. In this role you will be responsible for regulatory coordination of clinical research studies within assigned units,… more
- Terumo Neuro (Aliso Viejo, CA)
- …consistent. + Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other ... accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH … more
- Abbott (Pleasanton, CA)
- …understand quality system requirements and how they impact product quality and regulatory compliance . + Represents the division within Abbott through Corporate ... field + Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance /Affairs experience in medical device manufacturing or other similarly… more
- PeopleReady (Chatsworth, CA)
- …nutrition labeling, allergen statement, cooking instructions and regulatory information in compliance with CFR, USDA, FDA and other related laws and ... + Minimum 2 years of experience of label and regulatory affairs in the food industry + Previous experience...Must be familiar with CFR 9 and 21, USDA, FDA and other related laws and regulations + Knowledge… more
- Medtronic (Northridge, CA)
- …management, ensuring adoption and business impact. + Ensure compliance with all regulatory , audit, and FDA requirements in manufacturing and quality. + Drive ... partnerships with business leaders, and ensuring that technology enables productivity, compliance , and innovation. Spanish and English fluency is a strong plus.… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. ** Regulatory Compliance :** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration ... and IEC 62366 usability engineering activities with SDLC processes. **Training and Compliance :** 1. Provide ongoing training and education on quality systems and… more
- Mentor Technical Group (Redwood City, CA)
- …+ Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more