Quality and Regulatory Affairs Manager
Did you know that the average person can expect to break two bones in their lifetime? 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
Competitive salary package
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
Join us! Please send your motivation letter and resume to recruitment@slamortho.com
