Quality and Regulatory Affairs Manager (contract or freelance)

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. In this role, you will work work in a small team of driven engineers on our quality and regulatory systems, directly improve patients’ lives, and contribute significantly to enhancing the quality of our healthcare system.

Responsibilities:

• Maintain and improve the Quality Management System (QMS) in compliance with relevant regulations and standards, including EU MDR and ISO13485.  

• Lead the preparation of documentation for regulatory submissions (EU Notified Body/FDA) and serve as the primary regulatory contact.

• Conduct internal audits to ensure adherence to quality processes and identify areas for improvement.

• Support manufacturing and supply chain activities, including nonconforming material control, acceptance testing, part qualification, and process validation.

• Manage and maintain accurate, up-to-date, and accessible documentation related to quality processes, procedures, and test records.

• Maintain the training matrix and ensure appropriate training for team members and suppliers.

• Collaborate closely with engineering, manufacturing, and commercial teams to integrate quality processes throughout the product lifecycle.

• Provide guidance on quality-related issues and support continuous improvement initiatives.

Requirements:

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences) or 3-5 years of work experience in a similar QMS role

• In-depth knowledge of relevant regulations and standards, including EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO14971

• Strong analytical and problem-solving skills

• Excellent communication and collaboration abilities

What we offer

• Competitive salary package

• Stock Appreciation Rights, providing you with a stake in the company’s success

• An inspiring and collaborative work environment with a team of highly ambitious and talented individuals

• A down-to-earth and supportive company culture with various social activities

• The rewarding experience of seeing your work directly improve patient outcomes