Quality and Regulatory Manager

Job Title: Quality and Regulatory Manager (Medical Devices) Reports to: Director of Quality / Head of Operations Job Summary The Quality and Regulatory Manager is responsible for ensuring that all medical device products comply with global regulatory requirements (e.g., US FDA, EU MDR, ISO 13485), maintaining effective quality management systems, and facilitating successful regulatory submissions. The role involves leading internal and external audits, managing documentation, and supporting cross-functional teams to ensure the safety, efficacy, and compliance of medical devices throughout the product lifecycle. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations. Lead internal and external audits, and manage corrective and preventive action (CAPA) processes. Ensure proper documentation, control, and retention of quality records and regulatory files. Oversee product nonconformance investigations and ensure timely closure of deviations. Regulatory Affairs: Prepare, compile, and submit regulatory filings (510(k), CE Mark Technical Files, etc.) for new and existing products in global markets. Monitor and interpret global regulatory changes, ensuring the company remains in compliance. Serve as primary contact for regulatory agencies and notified bodies during inspections and audits. Develop and maintain product registration dossiers and technical documentation. Risk Management: Lead risk management activities in accordance with ISO 14971, including hazard analysis and post-market surveillance. Support product recalls, field safety corrective actions, and complaint investigations. Training & Continuous Improvement: Train and mentor staff on quality and regulatory requirements. Drive continuous improvement initiatives for product and process quality. Cross-Functional Support: Collaborate with R&D, Manufacturing, Supply Chain, and Marketing to ensure compliance in product design, labeling, packaging, and advertising. Support new product development teams with regulatory strategy and submission pathways. Qualifications & Requirements Bachelors or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field. Minimum 2 years’ experience in quality and/or regulatory roles in the medical device industry. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards/regulations. Experience preparing regulatory submissions (510(k), PMA, CE Mark, etc.). Lead Auditor certification for ISO 13485 (preferred). Excellent written and verbal communication skills. Strong organizational and project management abilities. Key Competencies Detail-oriented and analytical. Problem-solving and decision-making skills. Ability to work cross-functionally and lead teams. Up-to-date with global regulatory trends and requirements. Location: [Insert location] Employment Type: [Full-time/Part-time/Contract] Let me know if you want to add anything about company culture, reporting structure, or specific product lines!