About the job
At docplanner, our Risk & Compliance team is pivotal in ensuring we adhere to regulatory standards while fostering innovative, safe, and scalable healthcare solutions. As we navigate the evolving landscape of medical devices, regulatory compliance becomes essential to our growth and global operations.
We are excited to announce the opening for a Senior Healthcare Regulatory Specialist (SaMD) to join our dynamic global team. In this role, you will serve as the Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR). You will collaborate closely with teams across Product, Engineering, Machine Learning and Data, Customer Care, and Legal to ensure our Software as a Medical Device (SaMD) offerings comply with regulatory requirements throughout Europe. Your contributions will be instrumental in enabling docplanner to operate safely and efficiently in a highly regulated digital healthcare environment.
This position presents an impactful opportunity to enhance our regulatory framework, directly supporting our strategic goals of EU MDR compliance and global expansion. You will gain valuable experience with cutting-edge healthtech and AI-driven products, working alongside cross-functional teams across various markets.
Your Impact:
- EU MDR Compliance: Achieve and maintain the necessary Medical Device Regulation certification to ensure access to the European market.
- Support Global Certification Processes: Lead MDR certification and other accreditation processes (ISO, C5) across targeted jurisdictions to facilitate market expansion.
- Establish Compliant Governance Framework: Develop robust governance systems that stakeholders and customers can trust, ensuring business integrity and adherence to regulations.
- Risk Mitigation & Business Protection: Proactively prevent regulatory fines and reputational damage that could hinder our ability to serve patients and healthcare providers.
- Process Optimization: Continuously evaluate and refine compliance processes to align with the dynamic requirements of the increasingly regulated digital healthcare sector.

