The Senior Compliance Engineer ensures electromechanical cardiac devices meet global regulatory, safety, and environmental standards throughout their lifecycle.
They provide technical leadership on electrical safety, design control, labeling, and material compliance, collaborating across Engineering, Quality, Regulatory, and Manufacturing.
Responsibilities include evaluating compliance for new and existing designs, supporting regulatory submissions, maintaining audit-ready documentation, and guiding early-stage development to streamline approvals.
Requirements include a relevant engineering degree with 3-5+ years of experience, strong knowledge of medical device standards (IEC 60601, ISO 14971, EU MDR, FDA), and excellent communication and organizational skills.
Offering a competitive salary, comprehensive benefits, and opportunities to make a meaningful impact in healthcare.