Job
Description
Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, user support, and maintenance. Manage controlled document lifecycles, ensuring version control, timely reviews, and audit readiness. Promote compliance awareness across delivery teams and collaborate with cross-functional stakeholders. Demonstrate strong problem-solving, communication, and virtual collaboration skills, with the ability to explain risk to non-technical teams. Required Experience and Educational Qualification: 10+ years of experience in medical device compliance or quality roles within the pharma, biotech, or medical device industry. Proven expertise in ISO 13485 implementation, audit participation, and regulatory compliance. Solid understanding of FDA 21 CFR Part 820, EU MDR (Regulation (EU) 2017/745), and international medical device standards. Experience with depot and shipping logistics for clinical or commercial medical devices. Strong analytical, documentation, and communication skills. Familiarity with EU authorized representative and UDI requirements. Knowledge of document control processes in support of GxP operations (GMP, GVP, GCP). Familiarity with change control, IT compliance, and CAPA systems.
