Barbara Chalef serves as a Senior Regulatory Affairs Specialist at Medtronic, where she plays a pivotal role in ensuring that the company’s diverse portfolio of medical devices meets stringent regulatory requirements across multiple jurisdictions. With her extensive expertise in global regulatory compliance, Barbara is adept...
Barbara Chalef serves as a Senior Regulatory Affairs Specialist at Medtronic, where she plays a pivotal role in ensuring that the company’s diverse portfolio of medical devices meets stringent regulatory requirements across multiple jurisdictions. With her extensive expertise in global regulatory compliance, Barbara is adept at navigating the complexities of class I, II, and III medical device submissions, ensuring adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and privacy regulations such as HIPAA. Her responsibilities encompass supporting critical submissions, including 510(k) notifications, Premarket Approvals (PMA), and the EU Medical Device Regulation (MDR) 2017/745 technical documentation.
Barbara’s current projects involve developing and managing Change Order Assessments, which are essential for maintaining compliance during product modifications. She interfaces regularly with Notified Bodies, the FDA, and other Health Authorities, ensuring that all submissions are meticulously prepared and align with regulatory expectations. Her analytical skills and data analysis capabilities allow her to assess risks effectively, contributing to quality assurance and quality control (QA/QC) processes that safeguard patient safety and product efficacy.
In addition to her regulatory expertise, Barbara is committed to business process improvement, continuously seeking ways to streamline submission processes and enhance operational efficiency. Her comprehensive understanding of the new device approval process, alongside her ability to manage budgets and resources effectively, positions her as a key contributor to Medtronic’s mission of advancing healthcare technology. With a focus on fostering collaboration across departments, Barbara ensures that regulatory strategies align with broader business objectives, ultimately driving innovation in medical device development.
