Quality & Regulatory Lead – MedTech

Amber Implants; Den Haag; Hybrid; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Friday drinks and company events

Canteens in building with warm meals/咖

Gym access discount

Job summary

Amber Implants, based in The Hague, seeks a Quality Manager to lead and strengthen its QMS in line with ISO 13485 and MDR. You will oversee Class III device release, equipment qualification, and supplier quality, ensuring regulatory compliance and scalable, lean quality practices as the company grows.

This hands-on role partners with R&D, Operations, and Clinical teams, advancing regulatory submissions and post-market surveillance while driving continuous improvement across the organization.

Qualifications

• 3+ years of experience in a similar role managing medical device quality activities.
• Proven knowledge of Quality Management principles per ISO 13485.
• PRRC qualification or ability to obtain per EU MDR Article 15.
• Experience with ISO 14971 risk management and FDA QSR/CE marking processes.

Responsibilities

• Maintain ISO 13485:2016 and 21 CFR Part 820 compliant QMS and related documentation.
• Serve as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Prepare, review, and control quality documents, work instructions, forms, and records.
• Lead CAPAs, non-conformities, deviations, complaints, and quality investigations.
• Coordinate internal audits and support supplier and Notified Body audits.
• Support regulatory activities including technical documentation and conformity assessments.
• Provide QMS training and ensure lean, scalable quality processes.

Skills

Quality mindset

Communication skills

English proficiency

Cross-functional collaboration

Education

University degree in biomedical engineering or related field

Tools

Microsoft Office

Job description

Amber Implants, based in The Hague, seeks a Quality Manager to lead and strengthen its QMS in line with ISO 13485 and MDR. You will oversee Class III device release, equipment qualification, and supplier quality, ensuring regulatory compliance and scalable, lean quality practices as the company grows.

This hands-on role partners with R&D, Operations, and Clinical teams, advancing regulatory submissions and post-market surveillance while driving continuous improvement across the organization.