Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly within Spain)
Docplanner is seeking a Senior Healthcare Regulatory Specialist (SaMD) to join our global Risk & Compliance team. In this role, you will act as the Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR), ensuring our Software as a Medical Device (SaMD) products meet regulatory requirements across Europe. This position is remote-friendly within Spain.
Key responsibilities include achieving mandatory MDR certification to maintain European market access, leading MDR certification and other accreditation processes (such as ISO and C5) across target jurisdictions, and building robust governance systems to ensure business integrity and regulatory adherence. You will also focus on risk mitigation to prevent regulatory fines and reputational harm, and continuously assess and improve compliance processes to align with the dynamic needs of the digital healthcare industry.
The ideal candidate will have strong knowledge of EU MDR, particularly in a SaMD context, practical experience in medical device regulatory affairs, and a solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks. A relevant academic background in law, medicine, pharmacy, engineering, or a scientific field, or equivalent hands-on experience in medical device regulatory/QMS, is required. Experience with EUDAMED, CAPA systems, and post-market surveillance tools is essential. The role requires the ability to manage cross-functional regulatory projects independently, strong communication skills with both internal teams and external regulatory authorities, and fluency in English; proficiency in Spanish or other EU languages is a plus.
Docplanner offers a range of benefits, including healthcare insurance, wellness programs, flexible time off, and an Employee Stock Option Plan (ESOP) after six months. Depending on your location, additional perks such as meal vouchers, transport allowances, or extended parental leave may be available. We are committed to career growth, providing opportunities to learn, develop, and explore new paths within the company.
At Docplanner, we value results, ownership, simplicity, respect, and curiosity. We are a diverse and inclusive team, working together to make a real impact in the healthcare industry. Joining us means contributing to a mission that truly makes a difference.