- Medtronic (Los Angeles, CA)
- …our technology transforms lives Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or ... resolutions to meet goals and objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory… more
- Zimmer Biomet (Englewood, CO)
- …ISO 13485, 21 CFR 820, ISO 10993 (biocompatibility), and others relevant to medical device development and manufacturing. * Support internal and external audits ... equivalent combination of education and experience. * Experience working within medical device quality management systems (QMS) * Experience with ISO 13485 and… more
- Mentor Technical Group (Durham, NC)
- …the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... HVAC systems within a regulated industry (such as pharmaceutical, biotech, medical device , or food manufacturing) and a strong commitment to compliance, safety,… more
- GE HealthCare (Troy, NY)
- …maximizing throughput + Lead and support documentation activities related to medical device manufacturing, ensuring compliance with regulatory requirements + ... a high-performing, collaborative work environment. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve… more
- Philips (Plymouth, MN)
- …if:** + You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of ... the QMS related to Design/Process Controls. + You have strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR… more
- Teleflex (Morrisville, NC)
- …(8) years relevant engineering experience in a regulated industry required with medical device development experience required. **Specialized Skills / Other ... functions and locations. * Working knowledge of quality systems and medical device regulations (ISO13485). * Experience with Solidworks 3D modeling. * Working… more
- Integra LifeSciences (Plainsboro, NJ)
- …of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in the medical device… more
- Mentor Technical Group (Ponce, PR)
- …the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... and have at least two years of experience in validation within a medical device company. + Validation lifecycle knowledge / Hands on experience (Writing and… more
- Bausch + Lomb (Kirkwood, MO)
- …Objective: Plan and manage/coordinate resources and activities related to ophthalmic medical device product development projects throughout Surgical R&D using ... Champion and lead projects as a project manager for ophthalmic medical device products (Electrical/Mechanical/Software-driven Capital Equipment and associated… more
- Integra LifeSciences (Plainsboro, NJ)
- …of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in the medical device… more