Senior Healthcare Regulatory Specialist (SaMD)

TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Leading EU MDR certification and regulatory compliance governance for medical software products with an accent on Quality Management Systems and post-market surveillance. Focus on building robust regulatory frameworks, mitigating compliance risks, and ensuring safe market access across European digital healthcare environments.

Location: Must be based in Spain (Remote-friendly)

Company

hirify.global is the world’s largest healthcare platform, connecting millions of patients with medical professionals through integrated SaaS and AI tools to simplify and improve care.

What you will do

• Achieve and maintain mandatory EU Medical Device Regulation (MDR) certification.
• Lead regulatory accreditation processes including ISO and C5 to facilitate market expansion.
• Design and implement robust governance systems to ensure regulatory adherence and business integrity.
• Manage risk mitigation strategies to protect company reputation and service continuity.
• Collaborate with product, engineering, and data teams to align compliance processes with digital health innovation.

Requirements

• Must be based in Spain and hold the legal right to work in the country.
• Strong expertise in EU MDR, specifically within a Software as a Medical Device (SaMD) context.
• Practical experience managing Quality Management Systems (QMS) and regulatory governance frameworks.
• Proficiency with EUDAMED, CAPA systems, and post-market surveillance tools.
• English language proficiency (C1 level).
• Academic background in law, medicine, pharmacy, or engineering, or equivalent regulatory experience.

Nice to have

• Knowledge of the EU AI Act.
• Familiarity with Agile software development environments.
• Fluency in Spanish or other EU languages.

Culture & Benefits

• Healthcare insurance and wellness support.
• Flexible remote work policy and adaptable hours.
• Generous time-off policies including vacation and recharge days.
• Opportunities for professional growth and cross-functional project involvement.
• Diverse, global team environment.

Hiring process

• Introductory chat with Talent Partner.
• Business case study with team presentation.
• Technical interview focused on EU MDR and compliance experience.
• Operational interview for QMS and team fit.
• Final culture and values interview.