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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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Non-profit Organizations and Primary and Secondary Education
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