Senior Technical Services Manager (Medical Device)

Responsibilities:Develop and maintain written policies and procedures around complaint handling and regulatory reporting per the ARDx global QMS as well as US and European (as well as other geographies where ARDx product is sold) to ensure thorough, consistent and timely documentation and routing of complaint informationProvide Subject Matter Expert support for internal and external audits of the Technical Services and Complaint Intake functionsDemonstrate commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.Job Type: Full-timeQualifications:Minimum of 8 years in the medical device sector working in a similar capacityExpert knowledge of medical device / diagnostics post-market surveillance regulations (e.g. US FDA 21 CFR Part 803 / 820, ISO 13485, Meddev)Relevant Science/Bio medical qualification essential.Strong people management skills with a proven ability to establish and manage multiple lingual and cross functional teamsAble to travel internationallyMulti-lingual capability would be an advantage but cultural sensitivity is a necessityExpert knowledge of diagnostics on clinical and technical level.Exceptional service orientation and focus, experience in customer service methods and techniques.Advanced knowledge of systems with software and hardware components.