Hyfe Inc. is seeking a Regulatory & Quality Documentation Specialist to author design documentation for a SaMD product aimed at the Japanese market.
You will support STED documentation, PMDA responses, and QMS improvements while coordinating with a global, remote team. Requirements include advanced English, 2+ years in medical device or SaMD regulatory affairs, and the ability to work independently across time zones (ET to Japan/Europe).
Remote SaMD Regulatory & Quality Documentation Specialist in Ottawa employer: Hyfe
Hyfe Inc. is an exceptional employer that fosters a collaborative and innovative work culture, allowing you to thrive as a Remote SaMD Regulatory & Quality Documentation Specialist. With a focus on employee growth and development, we offer unique opportunities to engage with a global team while contributing to impactful projects in the medical device sector. Our commitment to flexibility and inclusivity ensures that you can balance your professional aspirations with personal well-being, making Hyfe a rewarding place to advance your career.
