We are hiring a full time Regulatory Affairs Manager with strong business judgement to shape and implement the regulatory strategy for our medical products. As our products combine hardware and software, your regulatory decisions will directly shape our products' success and market access. - Partner with management on regulatory risk assessment and market access decisions - Real ownership with direct strategic impact on product design and market access Tech Stack and Domain: regulatory strategy, regulatory submissions, technical documentation, clinical evaluation, PMS, PMCF, notified body, market access, digital health, wearable devices, medical devices - Related roles: Regulatory Affairs Specialist, Senior Regulatory Affairs Manager, Regulatory Affairs Lead, Regulatory Compliance Manager
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