Consultor Senior Regulatory Affairs

Medical Device Compliance Senior Consultant

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? As part of our ongoing growth and commitment to excellence, we are currently looking for a Medical Device Compliance Senior Consultant to join our international team in Barcelona .

Responsibilities

• Participate in multiple projects in the medical devices sector, ensuring timely delivery and adherence to project budget and customer needs.
• Support QA and RA activities at Medical Device Companies.
• Ensure compliance with regulatory requirements and quality standards, including regulatory activities for CE marking, MDR or IVDR certification (design and development activities, review of labelling materials, technical documentation preparation).
• Support Clinical Evaluation.
• Post Market Surveillance and Post Market Clinical Follow-Up.
• Support complaints investigation and report completion, including cybersecurity issues from post‑market.
• Support extra‑EU registration.

Qualifications

About the Company

PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

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