What we do

Your role

As the Team Lead Quality & Regulatory Affairs, you will be responsible for developing and executing regulatory strategies on a global scale while overseeing and maintaining the quality management system (QMS) in compliance with ISO 13485. You will ensure that all products meet applicable regulatory requirements and company standards, manage internal and external audits, and drive continuous improvement initiatives within the organization. Additionally, you will advise on data protection obligations, monitor compliance, and act as a point of contact for data subjects and supervisory authorities.

1. Regulatory Strategy
   • Develop and implement comprehensive regulatory strategies aligned with business objectives and market access plans.
   • Oversee the preparation, submission, and maintenance of regulatory filings globally.
2. Quality Management System (QMS)
   • Lead and maintain the QMS in accordance with ISO 13485 standards.
   • Ensure safety and compliance of our QMS processes as the Person responsible for Regulatory Compliance.
   • Provide training and support to staff on QMS processes, regulatory requirements, and best practices.
3. Audits and Compliance
   • Manage internal and external audits to ensure compliance with regulatory requirements.
   • Drive continuous improvement initiatives within the organization.
4. Data Protection
   • Monitor and develop the organization’s data processing strategies to ensure compliance with GDPR and other applicable data protection laws.
   • Provide training and support to staff on data protection obligations and best practices.
5. Stakeholder Engagement
   • Act as the in-house quality and regulatory expert, advising and supporting internal and external stakeholders.
   • Collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product lifecycle.

Your profile

• Bachelor’s degree or higher in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
• Minimum of 5 years of experience in the management of QMS within the medical device industry, with a strong understanding of ISO 13485.
• Proven leadership experience with strong decision-making capabilities.
• Extensive knowledge of global regulatory requirements and submission processes.
• Excellent communication, negotiation, and interpersonal skills.
• Strategic thinking and problem-solving abilities.
• High attention to detail and accuracy.
• Flexibility and adaptability to work in a fast-paced, dynamic environment with changing market conditions.

• Experience with applicable Data Privacy Laws is a plus.
• Experience with medical device software and ISO 27001 is desirable.
• Internal Auditor certification is highly desirable.

What we offer

• Work flexibly
  In-office? From home? Somewhere in between? Whatever you prefer.
• Team Culture
  We host regular team nights and events to foster company culture and cohesion.
• Connect at our AI Campus
  Meet some truly exceptional humans at the AI campus — home to countless inspiring startups, events, and opportunities to broaden your horizons.
• Competitive salary
  We regularly benchmark salaries within the tech and healthcare industry.
• Develop your career
  Dedicate yourself to impactful projects and have regular, meaningful career development sessions with your manager.