Senior Healthcare Regulatory Specialist (SaMD)

TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Ensures hirify.global's software as a medical device products comply with EU Medical Device Regulation (MDR) and other global accreditations, building robust governance frameworks and mitigating risks. Focus on leading MDR certification processes, establishing compliant governance, and optimizing compliance processes in a dynamic digital healthcare environment.

Location: Remote-friendly within Spain. Candidates must have the 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 through marketplaces, SaaS, and AI tools.

What you will do

• Achieve mandatory EU Medical Device Regulation (MDR) certification for European market access.
• Lead MDR and other global accreditation (ISO, C5) processes to enable market expansion.
• Establish robust and compliant governance frameworks for stakeholders and customers.
• Mitigate regulatory fines and reputational harm to protect business integrity.
• Continuously assess and improve compliance processes within the digital healthcare industry.

Requirements

• Strong knowledge of EU Medical Device Regulation (MDR), especially in a Software as a Medical Device (SaMD) context.
• Practical experience in medical device regulatory affairs and Quality Management Systems (QMS).
• Relevant academic background (law, medicine, pharmacy, engineering, or scientific) or equivalent experience.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Ability to manage cross-functional regulatory projects independently.
• Fluent in English (C1 equivalent).
• Must have the legal right to work in Spain; visa sponsorship is not available.

Nice to have

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

Culture & Benefits

• Healthcare insurance and wellness support.
• Time off for vacation, birthdays, and recharging.
• Employee Share Option Plan (ESOP) after 6 months.
• Local benefits depending on location (e.g., meal vouchers, transport allowances).
• Opportunities for career growth and cross-functional projects.
• Work with a diverse, global team.
• Flexible hours and remote work options, with hubs available in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome, or Bologna.

Hiring process

• Intro Chat with Talent Partner.
• Take-home Business Case with collaborative discussion.
• Technical Interview with potential manager and team.
• Operational Interview focusing on QMS integration and collaboration.
• Final Interview focused on cultural fit and strategic alignment.
• References & Offer.