We are partnering with a German based growing MedTech business focusing on the treatment of Skin Cancer. Our client is seeking a Senior Quality and Regulatory Manager with a strong background in quality management and regulatory affairs. About the job Senior Quality and Regulatory Manager Munich, Germany To be successful have a proven ability to collaborate with internal stakeholders, mentor junior peers, and manage external resources such as consultants and advisors. Establish and maintain Quality System requirements. Collaborate with junior peers to set and achieve quality and regulatory goals. Assist in regulatory preparations and negotiations for new markets; act as a contact for regulatory authorities in existing markets. Advise business teams on emerging quality and regulatory issues. Provide regulatory training and mentorship to staff across departments. Explain audit findings, resolve conflicts, and consult on corrective actions. Interface with Regulatory Agencies during inspections and audits. Represent the organization during client and regulatory audits. Prepare and guide site personnel for regulatory audits and compile audit reports. Track and report on corrective actions. Manage and review SOPs, QM-related documents, and Technical Documentation. Support Vendor Assessment, client audits, and subcontractor audits. Optimize Quality and Regulatory processes and ensure global QA/RA compliance. Required Qualifications Degree in engineering, biomedical, or related field; Master’s or MBA is a plus. 4+ years of experience in quality management and regulatory affairs for medical devices. Experience with submissions, technical documentation, and approval processes (MDD/MDR/De Novo/510(k)). In-depth knowledge of medical device QMS (ISO 13485 / 21 CFR 820). Experience managing external audits with notified bodies and competent authorities. Proficiency in medical device risk management (ISO 14971). Familiarity with standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series, and Post Market Surveillance. Strong coaching and mentoring skills. Fluent in English Sounds like a fit? Click apply. Please note, you will only be considered if you have the required experience listed.