Your responsibilities:

• Lead FDA remediation and compliance activities for Class III medical devices / combination products, ensuring sustainable resolution of compliance gaps and regulatory observations.
• Provide subject matter expertise in Design Verification & Validation (DVV), test method validation, manufacturing controls, lot release, and risk-based product development.
• Translate FDA feedback, Q-Sub outcomes, and regulatory requirements into practical testing, validation, quality, and manufacturing actions.
• Partner with Quality, Regulatory Affairs, R&D, Manufacturing, and external experts to strengthen FDA inspection readiness, QMS effectiveness, and overall compliance.

Your qualifications:

• Advanced degree in Engineering, Biotechnology, Life Sciences, or a related field.
• Several years of experience in FDA-regulated combination products.
• Demonstrated hands-on expertise in DVV, test method validation, process validation, QMS, and FDA combination product requirements (21 CFR Part 4).
• Strong working knowledge of FDA regulations and FDA remediation or inspection readiness programs, with the ability to provide practical, solution-oriented guidance.

What we offer:

• An interdisciplinary position with significant responsibility and ample room for initiative
• Short decision-making processes and an open, collaborative company culture
• The opportunity to work on innovative medical technologies with high clinical relevance
• A motivated team with strong technical expertise and a shared vision

Any questions?

If you have any questions, Ms. Kocamahhul would be happy to answer them – please do give her a call on +49 (0) 7231 980 84 134!