- Medtronic (Irvine, CA)
- …degree in science, communication, or a healthcare-related field + 4 years of medical device experience, including knowledge of the US and International ... and promotional material to ensure that it meets all medical , legal, and regulatory (MLR) process requirements....years' experience **Nice to Have:** + US and International medical device industry experience in Advertising &… more
- Meta (Sunnyvale, CA)
- **Summary:** As a Hardware Regulatory Readiness and Compliance Technical Program Manager at Meta, you will play a critical role in crafting our compliance strategy ... to ensure that our products meet regulatory requirements and industry standards. You will work closely with cross-functional teams to drive compliance across… more
- Stryker (San Jose, CA)
- …skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software ... 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a...+ Partner with cross-functional teams, including marketing, R&D, clinical, regulatory , and operations, to deliver quality, compliant products. +… more
- Stryker (San Jose, CA)
- …a related field + 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). + Experience leading and ... **Senior Project Manager, International Regulatory Affairs** _San Jose, CA / Flower Mound,...skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance,… more
- Terumo Neuro (Aliso Viejo, CA)
- …Management Professional (PMP) certification is highly desirable. 3. Strong knowledge of medical device development processes, regulatory requirements, and ... enhancements. + Stay current with industry trends, regulations, and best practices in medical device project management, and apply them to improve project… more
- Actalent (San Diego, CA)
- …receipt, and implementation of new and revised labeling. Required Skills: + Experience in medical device labeling and regulatory compliance + Proficiency in ... labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional collaboration to… more
- Caldera Medical (Westlake Village, CA)
- …* Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions. * Collaborate with ... complaints and working on CAPA. * Bachelor's degree preferred. * Experience working within medical device industry and familiarity with 21 CFR 820, and ISO 13485… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …marketing collateral to support clinical products + Ownership of on-time quality assessments, medical device reporting and health risk assessments to the FDA and ... bodies + Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design,...ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if… more
- US Tech Solutions (San Bruno, CA)
- …Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation ... and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in software… more