Global Digital Health Regulatory Affairs Lead

Werfen is seeking an experienced regulatory affairs professional to ensure compliance for digital health products across domestic and international regulations. The role involves preparing submissions for FDA, Health Canada, and EU Notified Bodies, and assessing regulatory impacts of software changes and cybersecurity updates.

The position requires strong writing, analytical skills, and the ability to work in a fast-paced Agile environment, with travel up to 5-10% and collaboration across R&D