Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly within Spain)

📋 Description

• • As a Senior Healthcare Regulatory Specialist (SaMD) at DocPlanner Group S.A., you will be instrumental in navigating the complex and evolving landscape of digital health regulations, specifically focusing on Software as a Medical Device (SaMD) products. This pivotal role operates within the Risk & Compliance team, a critical function ensuring Docplanner adheres to stringent regulatory requirements while fostering the development of safe, scalable, and innovative healthcare solutions. Your expertise will directly contribute to our ability to operate globally, build trust with our users, and drive sustainable growth in an increasingly regulated market.
• • You will serve as the designated Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR), a crucial designation that underscores the significance of your responsibilities. This involves close collaboration with a diverse range of internal teams, including Product, Engineering, Machine Learning and Data, Customer Care, and Legal. Your primary objective will be to guarantee that our SaMD products meet all applicable regulatory requirements across European markets, thereby enabling Docplanner to operate safely, compliantly, and at scale.
• • This is a newly created and highly impactful position, offering a unique opportunity to shape and strengthen Docplanner's regulatory framework. You will be at the forefront of one of our core strategic priorities: achieving and maintaining EU MDR compliance and facilitating our global expansion efforts. Your work will provide you with invaluable exposure to cutting-edge healthtech and AI-driven products, fostering a deep understanding of their regulatory implications.
• • Your responsibilities will extend to leading and managing critical regulatory processes. A key focus will be achieving mandatory Medical Device Regulation (MDR) certification, which is essential for maintaining and expanding our European market access. This involves meticulous planning, documentation, and execution of the certification process, ensuring all requirements are met to the highest standards.
• • Beyond EU MDR, you will support global certification processes, including other accreditations such as ISO standards and potentially C5 certifications, depending on target jurisdictions. This proactive approach to regulatory compliance will enable seamless market expansion and ensure the continued availability of our products in various regions.
• • A significant aspect of your role will be the establishment and maintenance of a robust and compliant governance framework. This framework must instill confidence in both our internal stakeholders and our customers, ensuring the integrity of our business operations and unwavering adherence to regulatory mandates. You will be responsible for designing, implementing, and overseeing these systems.
• • You will play a vital role in risk mitigation and business protection. By proactively identifying and addressing potential regulatory non-compliance issues, you will help prevent costly regulatory fines, safeguard our reputation, and ensure our ability to continue serving patients and healthcare providers without interruption.
• • Continuous process optimization is paramount. You will be expected to regularly assess and enhance our compliance processes, adapting them to the dynamic and ever-evolving needs of the digital healthcare industry. This includes staying abreast of new regulations, technological advancements, and best practices to maintain a leading edge in regulatory affairs.
• • You will be a key point of contact for regulatory authorities, liaising effectively to ensure smooth communication and timely resolution of any queries or issues. Your ability to represent Docplanner professionally and competently will be crucial in maintaining positive relationships with these bodies.
• • Furthermore, you will contribute to the development and implementation of our Quality Management System (QMS), ensuring it aligns with medical device regulations and supports our product lifecycle. This includes managing documentation, conducting internal audits, and driving corrective and preventive actions (CAPA) as needed.
• • Your role will also involve staying informed about emerging regulatory trends and legislation, such as the EU AI Act, and assessing their potential impact on Docplanner's products and operations. This foresight will enable us to adapt proactively and maintain a competitive advantage.
• • Ultimately, your impact will be measured by your ability to ensure Docplanner's products are not only innovative and effective but also compliant, safe, and trustworthy, thereby solidifying our position as a leader in the healthtech space.