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experience in the medical device, regulated industry, or pharmaceutical sector
Quality Engineering experience with product development
Hands-on experience with Design Controls / Design & Development
Strong understanding of medical device regulatory requirements
21 CFR Part 820
Software system design control / SaMD experience is preferred and considered exceptional
IEC 62366-1
Experience working within design control documentation, risk management, verification/validation, change control, and product development processes
MDR / MDD
ISO 14971
ISO 13485
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.