Responsibilities
- EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access.
- Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance.
- Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence.
- Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers.
- Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.
Requirements
- Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context.
- Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks.
- Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience.
- Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
- Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders.
- Strong communication skills with both internal teams and external regulatory authorities.
- Fluent in English
Nice to Have
- Spanish or other EU languages
- Knowledge of the EU AI Act.
- Familiarity with Agile / software development environments.
Benefits
- Healthcare insurance
- Wellness that works for you – from gym memberships to mental health support, we’ve got you covered.
- Time off that counts – whether it’s a vacation, your birthday, or just a day to recharge, we believe in balance.
- Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave.
- Career Growth – We’re growing, and so can you! You’ll find lots of chances to learn, develop, and explore new paths—whether within your team or through cross-functional projects.
- A Truly Global Team – Work with talented people from all over the world in a diverse and inclusive environment.
- Flexibility That Works for You – Remote work and flexible hours aren’t just buzzwords here. While the extent of flexibility depends on your role and team, we value results over rigid schedules. Prefer an office setting? You're welcome at any of our hubs in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna.
Work Arrangement
Hybrid
Team
Team size: 3,000+ employees
Additional Information
- Please note: At this time, we are not able to sponsor visas for this position. To apply, you must already have the legal right to work in your country of residence or the location of the role.
