- 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 ... of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. + A history of...market releases. + Product knowledge including product vigilance and medical device reporting. + High attention to… more
- Terumo Aortic (Sunrise, FL)
- …Exportability and Certificates to Foreign Government from US FDA + Prepare and submit medical device reports or vigilance reports. + Perform various other duties ... for the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with...college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5… more
- ZOLL Medical Corporation (Riverside, CA)
- …+ Provide ongoing education and training to hospital and office staff on medical device order requirements and workflows to achieve operational efficiencies. + ... university or equivalent combination of education and experience in sales. + Healthcare/ Medical Device (Clinical or Billing) experience preferred + Experienced… more
- Globus Medical, Inc. (Audubon, PA)
- …them with the necessary tools, knowledge, and skills to excel in a competitive medical device market. The ideal candidate will have a strong background in ... Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both...of 2 years of sales training, preferably within the medical device industry + Medical … more
- Stryker (San Jose, CA)
- …Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and ... activities to drive customer quality. You will oversee ongoing compliance , monitor performance, and drive continuous improvement for both...visualization and monitoring. + Exposure to Software as a Medical Device (SaMD), Software in a … more
- Nissha Medical Technologies (Buffalo, NY)
- …Product Introduction (NPI) will lead the successful onboarding and ramp-up of new medical device programs within a contract manufacturing environment. This role ... and DHFs (Design History Files). + Regulatory & Quality Compliance : Ensure new product launches meet FDA 21 CFR...or MBA preferred). + 10+ years of experience in medical device manufacturing, with at least 5… more
- Abbott (Maple Grove, MN)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives… more
- LSI Solutions (Victor, NY)
- …to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, ... while maintaining full Quality and Regulatory compliance with all standards that govern the design, development,...distributors, with direction. + Communicates with distributors for ROW medical device registration, with direction. + Maintains… more
- Takeda Pharmaceuticals (Lexington, MA)
- …GUI, labeling etc.) + Oversee or generate the HFE deliverables throughout medical device development (Examples: HFE Plan, Task Analysis, Use Specification, ... making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA)...applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and… more
- Abbott (Plymouth, MN)
- …help of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more