Quality and Regulatory Affairs Manager

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

Join SLAM Ortho as Quality and Regulatory Affairs Manager

At SLAM Ortho, we are dedicated to empowering trauma surgeons with innovative sensor technology, enabling them to provide superior care for patients with fractures.

By integrating state-of-the-art sensor technology, advanced analytics, and an innovative reusable platform, we enable surgeons to reduce surgery time and deliver precisely fitted implants, minimizing complications and accelerating patient recovery.

We’re a small, ambitious team - engineers, designers, and clinical experts working closely together. Things are not always fully defined, and that’s part of the job: you help us grow a compliant, smart, and practical Quality Management System (QMS) that people actually use.

As our Quality and Regulatory Responsible you will:

• Maintain and improve our QMS in line with EU MDR and ISO 13485 as the company grows.
• Lead preparation of documentation for regulatory submissions (Notified Body, FDA) and act as our primary contact for regulatory communication.
• Conduct internal audits and follow up on CAPAs - knowing when something is “good enough to proceed” and when to hit pause.
• Support manufacturing and supply-chain activities: nonconforming material control, acceptance testing, part qualification, and process validation.
• Keep documentation clear, usable, and accessible - not 120-page manuals that live in drawers.
• Maintain the training matrix and ensure the team (and suppliers) are properly trained.
• Promote a culture where quality is part of development, not a separate phase at the end.
• Integrate risk management and traceability early in the design process.
• Provide hands‑on help where needed - whether that’s updating a form, supporting a test, or closing a CAPA.

What you bring

• A Bachelor’s degree in Engineering, Life Sciences, or equivalent experience.
• 3–5 years in a Quality or Regulatory role 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.
• Practical experience with risk management, usability, IFUs, clinical evaluation, PMS plans, and CAPA systems.
• A balance between structure and pragmatism - you know when a document needs tightening and when a discussion does.
• Clear communication skills and the ability to help others understand the why behind quality.
• Experience in small companies or startups is a big plus.
• Comfort with ambiguity - early‑phase medtech comes with plenty of it.

What we offer

• You’ll be part of a small team navigating complex technical and regulatory challenges together to bring safe, meaningful innovation to surgeons and patients.
• You’ll thrive in a setting where growth comes from taking ownership - we value initiative, accountability, and the drive to make things better every day.
• A supportive company culture with various social activities.
• The unique chance to see your work improve surgical outcomes and patient care.