Regulatory Affairs Specialist

As a Regulatory Specialist, you will play a vital role in ensuring Unilabs' compliance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and equivalent frameworks across our laboratories in Europe. You’ll work cross-functionally to embed a culture of regulatory excellence and support regulatory oversight for projects, technical documentation, and compliance strategies.

Why Join Unilabs?

Unilabs is a leading diagnostic services provider at the forefront of integrated healthcare. Join a collaborative team where your regulatory expertise will directly impact patient safety, product compliance, and business success across Europe.

What You Bring

Regulatory Strategy & Culture

• Promote a strong culture of regulatory compliance through training, communication, and support.
• Educate internal stakeholders on regulatory fundamentals, programs, and tools related to product safety and performance.

Regulatory Compliance & Documentation

• Support the implementation and maintenance of IVDR and equivalent frameworks (e.g., IvDO).
• Assist in preparing and auditing Technical File dossiers across Unilabs units.
• Develop and maintain policies, procedures, and documentation related to product regulatory compliance.
• Perform regulatory assessments for suppliers and new business initiatives.
• Maintain the UL Regulatory Excellence tool, coordinating with country QARA to ensure accurate records and data integrity.

Monitoring & Continuous Improvement

• Support training and onboarding related to new or updated regulatory procedures.
• Contribute to regulatory reviews across markets and drive continuous improvement initiatives.

Business Integration & Support

• Set up and monitor regulatory intelligence systems.
• Support the local implementation of global initiatives to ensure alignment and compliance.
• Conduct regulatory assessments for local projects and business decisions.

Decision-Making Mandate

Within the scope of your role, you are empowered to:

• Advise teams on the regulatory implications of planned activities or services.
• Recommend compliance risk mitigation actions.
• Escalate issues involving significant regulatory risk or business impact.

Required Capabilities

• Strong understanding of IVDR and other relevant regulatory frameworks.
• Skilled in the preparation and review of technical documentation.
• Critical thinking and problem-solving skills in a regulatory context.
• Self-motivated, detail-oriented, and capable of working cross-functionally.
• Strong written and verbal communication skills in English (Spanish is a plus).

Education & Experience

• Bachelor’s degree or master’s degree in technical/ process engineering/QA/ Medical Device discipline, with significant related professional experience within the laboratory environment.

• Experience with medical device regulation and/or in-vitro diagnostic regulation.

• English fluent as a must (presenting, writing, reading).

• Minimum Years Recommended and/or Preferred: 3-5 years.