MedTech Quality & Regulatory Lead - Drive Safer Surgeries

SLAM Orthopedic; Delft; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Small, ambitious team

Social activities

Job summary

SLAM Ortho is seeking a Quality and Regulatory Affairs Manager to lead the QMS, ensure EU MDR and ISO 13485 compliance, and drive regulatory submissions with Notified Bodies. You will partner with engineering and manufacturing to integrate quality into product development from the start.

The role requires 3–5 years in medical device quality/regulatory functions, strong communication, and the ability to operate in a small, ambitious team.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or equivalent.
• 3–5 years in quality or regulatory roles within medical devices.
• Solid understanding of EU MDR, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Experience with Class IIa CE-marking and working with a Notified Body.

Responsibilities

• Maintain and improve the QMS in line with EU MDR and ISO 13485 as the company grows.
• Lead documentation for regulatory submissions and act as primary regulatory contact.
• Conduct internal audits and manage CAPAs; know when to proceed.
• Support manufacturing and supply-chain activities: nonconforming material control, acceptance testing, part qualification, and process validation.
• Keep documentation clear, usable, and accessible; maintain training matrix.
• Promote a culture where quality is integrated into development, not separate at the end.
• Integrate risk management and traceability early in the design process.
• Provide hands-on help updating forms, supporting tests, or closing CAPAs.

Skills

Quality management

Regulatory affairs

Documentation & QA

Communication skills

Ambiguity tolerance

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Risk management frameworks

Job description

SLAM Ortho is seeking a Quality and Regulatory Affairs Manager to lead the QMS, ensure EU MDR and ISO 13485 compliance, and drive regulatory submissions with Notified Bodies. You will partner with engineering and manufacturing to integrate quality into product development from the start.

The role requires 3–5 years in medical device quality/regulatory functions, strong communication, and the ability to operate in a small, ambitious team.