- Cordis (Irvine, CA)
- …identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices . + Regulatory Compliance: Stay up-to-date with ... Quality Engineer** will be responsible for ensuring that our medical devices meet the highest quality standards...regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing… more
- Edwards Lifesciences (San Diego, CA)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Actalent (Irvine, CA)
- …related field (Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong ... integrity and compliance of marketing claims associated with our medical devices . The ideal candidate will have...have a strong background in quality systems within the medical device industry and a proven ability… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …knowledge of risk management processes (ISO 14971) and cybersecurity considerations for medical devices . + Exceptional analytical and problem-solving skills. + ... The role involves developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of...compliance with FDA's guidance on device versus non- device functionality. + Prepare, submit, and manage regulatory… more
- Edwards Lifesciences (Los Angeles, CA)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... work experience + Minimum 8 years' experience in the medical device industry, with 5 of those...(PMA, IDE, 510(k)) for Class I, II, and III medical devices . + Ability to work effectively… more
- Philips (San Diego, CA)
- …business by coordinating regulatory activities and ensuring products meet relevant medical device standards and requirements. **Your role:** + Assists in ... ** Regulatory Affairs Business Specialist** In this role, you...affairs, quality compliance, product development or equivalent in the medical device industry strongly preferred. + Your… more
- J&J Family of Companies (Irvine, CA)
- …years of experience in a regulated environment including five years of direct experience with medical devices in the fields of technical or medical writing, ... and governance to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Associate Director will lead the strategy… more
- Amazon (Sunnyvale, CA)
- …products and services? Come make history with Amazon's Legal Department. Amazon's Devices legal team is looking for a talented transactional attorney to support ... our rapidly growing and evolving devices business. This business develops an exciting array of...on a range of operations, intellectual property, technology and regulatory matters, and provide day-to-day advice - Resolve issues… more
- Abbott (Alameda, CA)
- …engineering, or quality-related field. + 5+ years of experience in quality assurance or regulatory compliance in the medical device industry. + Strong ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more