CONSULTANT SENIOR F / H

PQE Group; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading consulting firm is seeking a Medical Device Compliance Senior Consultant to join their team in Barcelona. The role involves ensuring compliance with regulatory requirements for medical devices and supporting quality assurance activities. Ideal candidates will have over 3 years of experience in the medical device sector and expertise in both QA and regulatory affairs. This position offers the opportunity to work on international projects and enhance your skills.

Formación

• 3+ years of experience in similar roles in the Medical Device field.
• Knowledge of international and local MD regulations.
• Understanding of Quality Management System requirements.
• Familiarity with ISO 14971 and Risk Analysis techniques.

Responsabilidades

• Ensure timely delivery and adherence to project budgets.
• Support QA and RA activities.
• Ensure compliance with regulatory requirements.
• Support Clinical Evaluation and complaints investigation.

Conocimientos

Quality Assurance

Regulatory Affairs

Effective communication in English

Descripción del empleo

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

• 3+ years of experience in similar roles in the Medical Device field, with expertise in Quality Assurance and/or Regulatory Affairs of MD Industry.
• Knowledge of international and local MD regulations.
• Understanding of Quality Management System requirements, Risk management principles, Regulatory requirements and industry best practices.
• Familiarity with ISO 14971, Product Risk Management and Risk Analysis techniques.
• Technical skills related to medical device industry processes.
• Effective written and verbal communication in English.

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.