Senior Healthcare Regulatory Specialist (SaMD)

TL;DR

Senior Healthcare Regulatory Specialist (SaMD): Ensuring hirify.global meets regulatory requirements, focusing on EU MDR compliance and global expansion. Focus on building a robust governance framework, risk mitigation, and process optimization in the digital healthcare industry.

Location: Remote-friendly within Spain

Company

hirify.global Group is the world’s largest healthcare platform, connecting 24 million patients with 280k doctors across 13 countries monthly.

What you will do

• Achieve mandatory Medical Device Regulation certification to maintain European market access.
• Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance.
• 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 increasingly regulated 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 the equivalent hands-on experience in medical device regulatory/QMS 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; Spanish or other EU languages are a plus.

Nice to have

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

Culture & Benefits

• Access to healthcare insurance.
• Wellness programs from gym memberships to mental health support.
• Flexible time off policy.
• ESOP (Employee Share Option Plan) after 6 months.
• Remote work and flexible hours.

Hiring process

• Intro chat with Talent Partner.
• Business Case take-home exercise.
• Technical interview.
• Operational Interview.
• Final Interview.