Quality & Regulatory Affairs Manager

Job description

Tasks Quality Management System (QMS): - Maintain and further develop the QMS in accordance with applicable standards and regulations. - Ensure effective document control, record maintenance, and system updates. - Prepare and maintain quality reports (e.g. Product Quality Reviews, Management Review inputs). - Support internal and external audits and follow-up on findings. Regulatory Affairs: - Ensure regulatory compliance in applicable markets. - Support product registrations, changes, and lifecycle activities. - Monitor regulatory changes and assess impact on products and processes. - Coordinate third-party testing activities as required. Supplier & Customer Quality: - Lead and support supplier quality activities, including qualification, monitoring, and nonconformities. - Support customer quality topics such as complaints, investigations, and feedback evaluation. CAPA & Change Management: - Support and manage CAPA activities, including investigations, root cause analysis, implementation, and effectiveness checks. - Support Engineering Change Orders (ECOs) with focus on quality, regulatory compliance, and documentation integrity. Risk, PMS & Vigilance: - Support Post Market Survei...