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Regulatory Affairs Specialist

Regulatory Affairs Specialist

UnilabsBarcelona, Catalonia, ES
Hace más de 30 días
Tipo de contrato
  • Quick Apply
Descripción del trabajo

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.
  • Requirements

    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.
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    Regulatory Specialist • Barcelona, Catalonia, ES