Senior Healthcare Regulatory Specialist (SaMD)

TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Ensuring hirify.global's Software as a Medical Device products meet EU MDR and global regulatory requirements with an accent on achieving mandatory certification and establishing compliant governance frameworks. Focus on risk mitigation, business protection, and process optimization within the dynamic digital healthcare industry.

Location: Remote-friendly, must be based in Spain. Not able to sponsor visas. Must have legal right to work in Spain or country of residence.

Company

hirify.global Group is the world’s largest healthcare platform, connecting patients with doctors across 13 countries and simplifying daily tasks for healthcare providers.

What you will do

• Achieve mandatory Medical Device Regulation (MDR) certification for European market access.
• Lead MDR certification and other accreditations (ISO, C5) across target jurisdictions.
• Build robust governance systems to ensure business integrity and regulatory adherence.
• Mitigate regulatory fines and reputational harm to protect business operations.
• Continuously assess and improve compliance processes for the digital healthcare industry.
• Act as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR.

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, scientific field) or equivalent experience.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Ability to manage cross-functional regulatory projects independently.
• Strong communication skills with internal teams and external regulatory authorities.
• Fluent in English (C1+ level required).

Nice to have

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

Culture & Benefits

• Global healthcare insurance and wellness support provided.
• Generous time off for vacation, birthdays, and recharging.
• Employee Stock Option Plan (ESOP) after 6 months.
• Local perks depending on location (meal vouchers, transport allowances, extended parental leave).
• Opportunities for career growth and cross-functional projects.
• Work with a diverse, global team in an inclusive environment.
• Flexible remote work and flexible hours, with office hubs available in multiple cities.

Hiring process

• Intro Chat with Talent Partner to assess mutual fit.
• Take-home Business Case exercise followed by a collaborative discussion.
• Technical Interview about background, aspirations, and EU MDR/compliance experience.
• Operational Interview focused on QMS integration and cross-functional collaboration.
• Final Interview for cultural fit, values, and strategic alignment.