The post-market surveillance manager will be responsible for providing quality expertise and oversight in all aspects of compliance management for domestic and international medical devices. The contractor will be responsible for leading, supporting, and improving complaint handling systems, post-market surveillance systems, and health hazard evaluations. The support would include procedure creation/revision, implementing electronic systems, process improvement, and facilitation of inter-department meetings, training and documentation.
Bachelors degree in engineering, clinical sciences, related sciences or relevant related experience in a medically regulated industry
5 plus years of relevant experience.
Extensive experience with post-market surveillance, adverse event reporting, health hazard evaluations, and risk-based decision making.
Must be able to effectively interact with applicable regulatory agencies at the local and/or bureau level.