Principal Regulatory Affairs Specialist

Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback. Saluda Medical ’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota. At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives. As a Principal Regulatory Affairs Specialist, you will provide Regulatory Affairs support for product development, sustaining engineering projects and compliance based activities. In this role, you will develop regulatory strategies, prepare global regulatory submissions and partner with cross-functional teams to help ensure products meet regulatory requirements throughout the product lifecycle. What You'll Do: Provide guidance to cross-functional partners and junior regulatory affairs staff. Monitor new and changing regulations, assess business impact, and recommend appropriate actions. Review device labeling, advertising, and promotional