Regulatory Officer (m/f/d)

Regulatory Officer (m / f / d) The Regulatory Officer is responsible for ensuring that all medical devices placed on the market comply with applicable regulatory requirements throughout their lifecycle. This role supports the organization in obtaining and maintaining regulatory approvals, monitoring regulatory changes, and acting as a key interface between internal stakeholders, Notified Bodies, and Competent Authorities. The Regulatory Officer contributes to patient safety, regulatory compliance, and business continuity and supports the Quality Assurance Team by providing regulatory, clinical and quality assurance expertise to ensure that products and services meet internal, legal and customer requirements Key Responsibilities: Regulatory Compliance & Documentation  Ensure compliance with applicable regulations and standards (e.g. EU MDR, ISO 13485).  Support the preparation, review, and maintenance of technical documentation and regulatory submissions.  Assist in conformity assessment activities and lifecycle management of medical devices.  Verify regulatory compliance of labeling, IFUs, and promotional materials. Regulatory Submissions & Interactions  Prepare and maintain regulatory registrations and notifications (e.g. EUDAMED, national databases).  Support communication with Notified Bodies and Competent Authorities.  Contribute to responses to regulatory questions, deficiencies, and audit findings.  Support post market regulatory activities, including vigilance and field safety actions. Clinical Affairs and Post-Market Surveillance  Support clinical evaluation activities in accordance with MDR requirements.  Assist in regulatory review of clinical evaluations, post‑market clinical follow‑up (PMCF), and related documentation.  Support the application of risk management processes in accordance with ISO 14971  Manage the preparation and update of PMS plans, PMS reports, and Periodic Safety Update Reports (PSUR) where applicable.  Support the PRRC in ensuring that the reporting obligations as per medical devices regulations are fulfilled Monitoring & Intelligence  Monitor and assess changes in regulations, standards, and guidance documents.  Perform impact assessments for regulatory changes and support implementation.  Inform stakeholders of new or changing regulatory requirements. Cross-functional Collaboration  Work closely with R&D, Marketing and other departments to ensure regulatory compliance and timely creation of the technical documentation  Provide regulatory input during product development, changes, and lifecycle decisions.  Support internal and external audits from a regulatory perspective.  Support the creation of the annual quality planning and management review Education:  Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs Engineering or a related field Experience:  3-5 years of experience in a similar position Skills:  High level of integrity and attention to detail  Clear and professional communication skills (written and verbal)  Ability to work independently and collaboratively in cross functional teams  Structured and analytical thinking  Strong sense of ownership and accountability  Ability to prioritize and manage multiple tasks Technical Knowledge:  Good understanding of medical device regulations (e.g. EU MDR)  Knowledge of ISO 13485 and related standards  Ability to perform regulatory impact and gap assessments  Knowledge of MS suite  Proficiency in written and spoken English (German or French are a plus) If you are interested in gaining experience in a growing Luxembourg-based company and are analytical and detail- oriented, we would like to meet you. What we offer you? A fast-growing company, an international environment, exciting challenges, a dynamic workplace