Senior Healthcare Regulatory Specialist (SaMD)

TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Ensures hirify.global's SaMD products meet regulatory requirements, particularly EU MDR, and supports global certification processes with an accent on establishing compliant governance frameworks and mitigating regulatory risks. Focus on operating safely and compliantly in a regulated digital healthcare environment and enabling global expansion for healthtech and AI-driven products.

Location: Remote-friendly within Spain. Candidates must have legal right to work in Spain.

Company

hirify.global Group is the world’s largest healthcare platform, connecting 24 million patients with 280k doctors across 13 countries, using marketplaces, SaaS, and AI tools to simplify healthcare tasks.

What you will do

• Achieve mandatory EU Medical Device Regulation (MDR) certification to maintain European market access.
• Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions for market expansion.
• 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 ability to serve patients and healthcare providers.
• Continuously assess and improve compliance processes to align with the dynamic needs of the digital healthcare industry.

Requirements

• Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context.
• Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks.
• Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or equivalent hands-on experience.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders.
• Fluent in English.

Nice to have

• Knowledge of the EU AI Act.
• Familiarity with Agile / software development environments.

Culture & Benefits

• Access to healthcare insurance and wellness support.
• Flexible time off, including vacation, birthday leave, and days to recharge.
• Employee Share Option Plan (ESOP) after 6 months.
• Local perks depending on your location, such as meal vouchers or transport allowances.
• Opportunities for career growth, learning, and exploring new paths within a global team.
• Flexible and remote-friendly work options based in Spain.
• Work with talented people from all over the world in a diverse and inclusive environment.

Hiring process

• Initial chat with a Talent Partner to explore mutual fit.
• A take-home Business Case exercise with dedicated prep time, followed by a collaborative discussion.
• Technical Interview about background, aspirations, and experience with EU MDR and compliance.
• Operational Interview focused on QMS integration and cross-functional collaboration.
• Final Interview for cultural fit, values, and strategic alignment.