QA/RA Specialist – Biological Materials / Animal Tissue (m/f/d) in Hechingen

We are looking for a QA/RA Specialist – Biological Materials / Animal Tissue to take operational ownership of regulatory and quality activities associated with animal-derived biological materials used in Class III implantable cardiovascular medical devices, particularly tissue heart valves.

About the Role

This specialized role combines biological science, Regulatory Affairs, Quality Assurance and supplier compliance.

You will work directly with animal-tissue suppliers, support Notified Body submissions and progressively develop into a subject-matter expert for ISO 22442 and animal-derived biological materials.

Responsibilities

• Prepare, review and maintain QA/RA documentation for animal-derived biological materials and tissue suppliers.
• Prepare and coordinate Notified Body submissions for new/alternative suppliers and relevant supplier, sourcing or process changes.
• Support and maintain compliance with the ISO 22442 series and applicable EU MDR requirements.
• Review scientific/regulatory evidence covering animal origin, geographical sourcing, veterinary and slaughterhouse controls, traceability, tissue processing, TSE/BSE risk, infectious-agent risk and viral/microbiological safety.
• Act as a key QA/RA interface with animal-tissue suppliers and other relevant external partners; define documentation requirements, identify gaps and coordinate remediation.
• Travel expectations due to audits and coordination activities.
• Support supplier qualification/requalification, audits, quality/regulatory agreements, change control, deviations and CAPAs.
• Assess supplier, sourcing and process changes for regulatory/quality impact and support Notified Body notification or approval where applicable.
• Maintain relevant Technical Documentation and risk-management content and ensure alignment with supplier evidence and regulatory submissions.
• Coordinate responses to Notified Body questions, deficiencies and audit findings related to biological materials.
• Monitor relevant regulatory and standards developments and translate new requirements into practical internal and supplier actions.
• Collaborate closely with RA, QA, Supplier Quality, R&D, Manufacturing, Procurement/Supply Chain, Clinical Affairs and other technical functions.

Qualifications

• University degree (BSc, MSc or equivalent) in Biology, Biotechnology, Microbiology, Molecular Biology, Biochemistry, Veterinary Science, Biomedical Sciences, Life Sciences or a closely related biological discipline.
• Approximately 2–4 years of experience in Regulatory Affairs, Quality Assurance, Supplier Quality, medical devices, biotechnology, pharmaceuticals or another regulated life-science environment.

Strong candidates with less experience may also be considered.

• Required Skills
• Strong scientific foundation and ability to critically evaluate biological and technical documentation.
• Knowledge of EU MDR and medical-device regulatory requirements; experience with Notified Bodies is advantageous.
• Knowledge of ISO 22442, ISO 13485 and ISO 14971 is strongly preferred, or the ability to develop this expertise rapidly.
• Experience with animal-derived tissues, tissue heart valves, Class III implantable devices, biological safety, supplier qualification, TSE/BSE assessment or infectious-agent risk is a significant advantage, but not mandatory.
• Structured, precise and independent working style with strong documentation discipline and attention to detail.
• Confidence communicating with suppliers and cross-functional stakeholders and constructively challenging incomplete or insufficient documentation.
• Fluent written and spoken English; very good German is strongly preferred.
• Preferred Skills
• Existing ISO 22442 or heart-valve experience is a major advantage but is not mandatory for a scientifically strong candidate with relevant QA/RA potential.
• Equal Opportunity Statement

We are committed to diversity and inclusivity.