CONSULTANT SENIOR F / H

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 . This is a unique opportunity to contribute to high-impact projects, working alongside top-tier professionals in an innovative and fast-paced environment.

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 (e.g., Support 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 , Post Market Clinical Follow-Up

Support complaints investigation and report completion, including cybersecurity issues from post-market

Support extra-EU registration

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

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