Senior Healthcare Regulatory Specialist (Healthcare)

TL;DR

Senior Healthcare Regulatory Specialist (EU MDR / SaMD): Managing regulatory compliance and certification for Software as a Medical Device products with an accent on regulatory governance and risk mitigation. Focus on leading MDR certification, establishing compliant governance frameworks, and ensuring European market access.

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

Company

The world's largest healthcare platform connecting millions of patients with doctors across 13 countries through SaaS and AI tools.

What you will do

• Lead EU MDR certification processes to maintain and expand European market access for SaMD products.
• Manage global accreditation processes, including ISO and C5, across target jurisdictions.
• Build and implement robust regulatory governance systems to ensure business integrity.
• Mitigate regulatory risks to prevent fines and protect the company's reputation.
• Continuously optimize compliance processes to align with the dynamic digital healthcare industry.

Requirements

• Strong expertise in EU Medical Device Regulation (MDR), specifically for Software as a Medical Device (SaMD).
• Practical experience in medical device regulatory affairs and Quality Management Systems (QMS).
• Academic background in law, medicine, pharmacy, engineering, or a scientific field.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Fluent English proficiency.
• Must have the legal right to work in Spain; visa sponsorship is not provided.

Nice to have

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

Culture & Benefits

• Global benefits including healthcare insurance and mental health support.
• Flexible work arrangements with remote-friendly options and flexible hours.
• Professional development opportunities through cross-functional projects.
• Diverse and inclusive global team environment.
• Local perks such as meal vouchers and transport allowances depending on the hub.

Hiring process

• Introductory chat with a Talent Partner.
• Business Case: Take-home exercise followed by a collaborative discussion.
• Technical and Operational interviews focusing on EU MDR, QMS, and cross-functional collaboration.
• Final interview focused on cultural fit and strategic alignment.