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

About the company

At Acandis, scientific expertise and technological innovation come together in an international, interdisciplinary team. Flat hierarchies and an open work environment give you the space to contribute ideas, take responsibility, and achieve great things together.

Your tasks

• 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.

Requirements

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.

• 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

How to apply

Any questions? We look forward to your call!

Melissa Kocamahhul HR Specialist +49 7231 980 84-134

Other

We are looking to fill this position as soon as possible

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