Teleflex - Mansfield, MA
posted about 1 month ago
The Compliance Engineer, Quality Systems at Teleflex plays a crucial role in ensuring adherence to applicable regulations and standards within the medical device industry. This position operates under the guidance of the Quality Manager and collaborates with various global resources to enhance and maintain the quality management system (QMS) in compliance with ISO 13485, the Medical Device Directive (MDD), the Medical Device Regulation (EU-MDR), and MDSAP International Regulations across multiple countries including Australia, Brazil, Canada, Japan, and the USA. The role requires a proactive approach to multi-site collaboration with Teleflex Medical offices and other departments to ensure that quality systems are not only compliant but also continuously improved. The Compliance Engineer will leverage their understanding of FDA regulations and global compliance trends to assist in various projects, applying regulatory compliance principles specifically tailored for medical devices. This includes the ability to develop and remediate design history files and technical files, ensuring that all documentation meets the necessary standards. The position also demands experience in Software as a Medical Device (SaMD) and software validation, as well as a solid working knowledge of US FDA quality system regulations, ISO 13485:2016, ISO 14971, and EU medical device regulations (MDR) and in vitro diagnostic regulations (IVDR). In addition to regulatory compliance, the role involves evaluating validation packages, developing communications for regulatory bodies, and attending agency meetings. The Compliance Engineer will work closely with cross-functional teams, including Research and Development, Marketing, Operations, and Regulatory Affairs, to perform gap analyses on revised standards and execute deliverables that ensure ongoing compliance. The position requires a diverse background in various classes and families of medical devices, as well as the ability to analyze complex data to identify quality signals and solve intricate quality-related problems, including managing non-conformances, deviations, and CAPA (Corrective and Preventive Actions). Overall, this role is pivotal in promoting awareness of regulatory and QMS requirements throughout the organization.