Seeking a Sr. Compliance Engineer to ensure electromechanical cardiac devices meet global regulatory, safety, and environmental standards throughout their lifecycle.
Responsibilities include leading compliance evaluations, interpreting standards (IEC 60601, ISO 14971, FDA, EU MDR), supporting labeling and documentation, assessing design impacts, and maintaining audit-ready records.
The role involves collaboration with engineering, quality, regulatory, and suppliers to ensure products are compliant, supporting regulatory submissions, and participating in audits.
Minimum requirements include a relevant engineering degree with 3-5 years of experience, strong knowledge of medical device standards, risk management, and regulatory frameworks, along with excellent communication and organizational skills.
The position offers a salary range of $120k–$135k, comprehensive benefits, and opportunities for professional growth in a global healthcare environment.