Leonid Group has been retained by a globally recognized and high-growth healthtech platform to appoint a Senior Regulatory Specialist (Medical Devices) to take a lead role in aligning their newly developed product(s) with regulatory requirements, based in Spain.
What began as a marketplace connecting patients with doctors has evolved into a multi-product platform spanning SaaS, AI-driven tools, and increasingly, Software as a Medical Device (SaMD). As the business moves further into regulated territory under EU MDR, this hire will play a critical role in enabling that transition.
Reporting into the Global Head of Risk & Compliance, you will act as the Person Responsible for Regulatory Compliance (PRRC), partnering closely with Product, Engineering, Data and Legal teams. This is a genuinely greenfield opportunity and you will be responsible for building and embedding medical device regulatory frameworks in a fast-paced, product-led environment.
This role can be based anywhere in Spain (remote first) with some travel including to one of the main offices in Barcelona. Due to the nature of the role, the successful candidate must be physically living and working in Spain or able to relocate there for the position.
What’s on offer?
The business is at the early stages of its medical device journey, with products evolving into regulated classifications. As a result, this is not about maintaining existing frameworks, it’s about building them from scratch.
You will step in as the go-to SME subject matter expert for EU MDR and medical device regulation, leading the transition of products into compliant SaMD, shaping QMS and governance structures, and acting as the key liaison between the company and regulators/competent authorities.
As the business has developed products into this space over the last two years, you will be joining as the key expert on medical device regulations and therefore will have real autonomy, visibility, and the opportunity to define how the frameworks are built.
The business is still in hyper-growth mode and employees are rewarded both in salary and a competitive ESOP program.
What they want from you:
You will bring hands-on experience in medical device regulatory affairs, with strong knowledge of EU MDR. Due to the requires for PRRC, you must have either a university degree (or equivalent) in Law, Medicine, Pharmacy, Engineering or another relevant scientific discipline and/or at least four years of professional experience in regulatory affairs or QMS relating to medical devices.
This is a technical, specialist role, requiring someone comfortable operating as a true expert. You’ll also be motivated by the opportunity to step into a greenfield environment, building frameworks from first principles and working cross-functionally with Product and Engineering teams.
Experience with QMS, certification processes, and regulatory tools (e.g. EUDAMED, CAPA, post-market surveillance) is important.
Fluency in English is required; additional EU languages are a plus.
If you’re looking to step into a role where you can build, own, and shape medical device compliance within a high-growth healthtech business, this is a standout opportunity.
Leonid Group Corporate Governance is a talent advisory firm that specialises in the placement of Legal, Compliance, Risk, ESG and Sustainability and Audit professionals on an international scale across the Americas, EMEA, and APAC. These are global disciplines with teams worldwide, and our network reflects this. We work with multinational corporations to help structure their departments with the best people, from the Global Chief Compliance Officer and General Counsel to the Compliance Analyst and Trade Compliance Specialist.