QA/RA Specialist, Biological Materials / Animal Tissue

The Opportunity We are looking for a QA/RA Specialist to take operational ownership of regulatory and quality activities associated with animal-derived biological materials used in our Class III cardiovascular devices. Your responsibility will be to collect and review the necessary documentation, follow up any gaps, and make sure it is correctly included in our Technical Documentation and Notified Body submissions. Your Responsibilities Prepare, review, and maintain QA/RA documentation for animal-derived biological materials and tissue suppliers. Prepare and coordinate Notified Body submissions for new or alternative suppliers and for relevant supplier, sourcing, or process changes. Support and maintain compliance with the ISO 22442 series and applicable EU MDR requirements (incl. the preparation of the necessary reports). Review the documentation provided by suppliers and follow up when information is missing, unclear or inconsistent. This includes animal origin sourcing and slaughterhouse controls. Keep the relevant Technical Documentation and risk-management files up to date. Assess supplier and process changes from a regulatory and quality perspective. Coordinate responses to questions and deficiencies raised by the Notified Body. Make sure that supplier information, internal documentation and regulatory submissions remain consistent. Keep track of relevant changes to regulations and standards and ensure these get translated into practical internal and supplier actions Work closely with RA, QA, Supplier Quality, R&D, Manufacturing, Procurement and Clinical Affairs. Support supplier qualification, quality agreements, deviations, CAPAs and change control where needed. Take part in supplier meetings and occasional supplier visits and/or audits. Your Profile Degree in biology, biotechnology, microbiology, molecular biology, biochemistry, veterinary science, biomedical sciences, or a related subject. Around 2–4 years of experience in Regulatory Affairs, Quality Assurance, technical documentation, or another regulated life-science environment. Experience with Class 3 implantable devices with animal tissue components is a must. Experience preparing or maintaining technical or regulatory documentation. Good understanding of EU MDR and medical-device requirements. Knowledge of ISO 13485 ISO 22442 and ISO 14971. Experience with Notified Body submissions or responses would be helpful. Able to understand scientific information and turn it into clear, structured documentation. Comfortable communicating with suppliers and asking for missing or additional information. Organized, careful and able to work independently. Fluent written and spoken English; good German is preferred. Willingness to travel occasionally. You do not need to be a full expert on animal tissues and cross-contamination topics. However, you must have a biological or life-science background and be comfortable working with scientific information related to the topic. #Hiring #RegulatoryAffairs #QualityAssurance #MedicalDevices #QARA #AnimalDerivedMaterials #Biomaterials #ClassIIIMedicalDevices #EUMDR #ISO13485 #ISO22442 #LifeSciencesJobs