FDA Quality & Validation Expert (f/m/d)

Are you an experienced FDA compliance professional with a strong scientific background, extensive knowledge of Quality Systems and a passion for driving operational excellence in the medical device industry? In this role, you will establish a DVV-strategy and support FDA remediation for the approval of highly innovative Class III combination product medical devices, with a particular focus on bio-functionalized neurovascular implants.

We are looking to fill this position as soon as possible

FDA Quality & Validation Expert (f/m/d)
Medical Technology

Pforzheim

• 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