The Senior Healthcare Regulatory Specialist (SaMD) will serve as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR), ensuring Docplanner's Software as a Medical Device (SaMD) products meet regulatory requirements across Europe. This role is critical in enabling compliant, safe, and scalable healthcare solutions as part of Docplanner’s global expansion and strategic focus on regulated digital health.
What You'll Do
- Act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR)
- Partner with Product, Engineering, Machine Learning and Data, Customer Care, and Legal teams to ensure SaMD products meet regulatory requirements across Europe
- Acquire mandatory Medical Device Regulation certification to maintain European market access
- Lead MDR certification and other accreditation processes (e.g., ISO, C5) across target jurisdictions to enable market expansion and continuance
- Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence
- Prevent regulatory fines and reputational harm that could impact the company's ability to serve patients and healthcare providers
- Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry
What We're Looking For
- Experience acting as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR
- Deep understanding of EU Medical Device Regulation (MDR) and its application to Software as a Medical Device (SaMD)
- Proven ability to lead MDR certification processes
- Experience working in regulated digital healthcare environments
- Strong collaboration skills with cross-functional teams including Product, Engineering, Legal, and Customer Care
Nice to Have
- Experience with additional certifications such as ISO or C5
- Experience supporting global market expansion in healthcare technology
- Familiarity with AI-driven healthtech products
- Experience working in multinational, remote-friendly environments
Team & Environment
- Global team with cross-functional collaboration across Product, Engineering, Machine Learning and Data, Customer Care, and Legal
- Reports to the Risk & Compliance team
Work Mode
- Remote-friendly role within Spain
Docplanner is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
