Director, Regulatory Affairs and Quality Assurance

Candidates must possess a Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field, with an advanced degree being preferred. A minimum of 8 years of experience in regulatory affairs within medical devices, digital health, or wearable technology is required, with a strong preference for experience in consumer-facing wearables. A proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals is essential, as is experience managing a quality system and undergoing external audits. Deep understanding of software as a medical device (SaMD) and cybersecurity regulations, along with experience in privacy and data regulations like HIPAA and GDPR, are necessary. Excellent leadership, communication, and stakeholder management skills are also required, along with the ability to thrive in a fast-paced startup environment.