- Philips (Colorado Springs, CO)
- …Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software. + Serving as SME for Software Design Assurance and collaborate ... years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design verification and/or… more
- Philips (Colorado Springs, CO)
- …health hazard evaluations, corrections and removals, and CAPAs as a regulatory SME . + Reviews labeling, marketing materials, and claims substantiation evidence to ... Regulatory Affairs within FDA and/or EU MDR regulated Medical Device environments. + Your skills include experience with 510(k)s,...their role and compensation decisions are dependent upon the facts and circumstances of each case. The actual base… more