We are looking for a highly skilled individual to assist the quality management and touchpoints with regulatory bodies across various business units or subsidiary companies with a specific focus on Europe and other regions. Responsibilities Establish and maintain Quality System requirements effectively. Collaborate with junior peers to set and achieve quality and regulatory goals. Assist in preparations and negotiations with regulatory agencies for new markets and act as a contact for existing markets. Ensure business teams consider the impact of current or emerging quality and regulatory issues. Provide regulatory training and mentoring to staff across various departments. Explain audit findings, resolve conflicts, and consult on corrective and preventative actions. Interface with Regulatory Agencies during inspections. Represent the organization during regulatory and client inspections/audits. Prepare site/operation personnel for regulatory audits and create summaries and reports of such audits. Track corrective actions and update management on their status. Perform general auditing duties to ensure compliance with quality standards. Assist in the final review and management of SOPs and QM-related documents. Assist with Vendor Assessment, client audits, and subcontractor audits. Manage Technical Documentation for submissions and product changes. Optimize Quality and Regulatory processes and ensure global QA RA compliance. Requirements: Degree in engineering, biomedical, or a related field; a Master's degree or MBA is a plus. 4 years of experience in quality management and regulatory affairs for medical devices. Proven experience handling submissions, technical documentation, and the approval process (MDD / MDR / De Novo or 510(k)). Specialist knowledge of medical device QMS (ISO 13485 / 21 CFR 820). Experience managing external audits with notified bodies and competent authorities. Experience in risk management of medical devices as per ISO 14971 and implementing various medical device standards. Knowledge of standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series, and conducting Post Market Surveillance activities is advantageous. Coaching and mentoring skills. Fluency in English and B2 level of German. Flexible, goal-oriented, and a team player.