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.
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.
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
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!