Senior Regulatory Affairs Specialist

Job description

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively. As our new Senior Regulatory Affairs Specialist, you will act as a key regulatory partner to R&D, ensuring that innovative hearing solutions – including software and AI-driven products – meet global regulatory requirements. This is an individual contributor role with significant impact, where you will drive regulatory excellence, support complex R&D projects, and help translate regulatory complexity into clear, actionable solutions. What you will do: Lead regulatory support for R&D projects, ensuring correct classification, intended use, regulatory strategy, and final product release Drive regulatory strategy for hearing aids, software, apps, and AI-based medical device projects, including implementation of AI-related requirements Advise on global medical device regulations including EU MDR, US FDA 21 CFR, and ISO 13485 requirements Ensure compliant technical documentation, l...