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 integral 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.

📌 Regulatory Affairs Specialist (Barcelona)
🏢 Empresa líder
📍 Barcelona