Medical Device Compliance Senior Consultant

PQE Group; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading consultancy in pharmaceuticals is seeking a Medical Device Compliance Senior Consultant in Barcelona. This role involves ensuring regulatory compliance, supporting QA and RA activities, and managing multiple projects in the medical devices sector. Ideal candidates have over 3 years of experience in the field, expertise in quality assurance, and strong communication skills in English. Join a dynamic team focused on high-impact projects in a multicultural environment.

Servicios

Opportunity for international projects

Collaborative, multicultural environment

Formación

• 3+ years of experience in similar roles in the Medical Device field.
• Expertise in Quality Assurance and / or Regulatory Affairs of the Medical Device Industry.
• Understanding of Quality Management System requirements.

Responsabilidades

• Participate in projects in the medical devices sector ensuring timely delivery.
• Support QA and RA activities at Medical Device Companies.
• Ensure compliance with regulatory requirements such as FDA and ISO 13485.

Conocimientos

Quality Assurance expertise

Regulatory Affairs understanding

Analytical skills

Effective communication in English

Descripción del empleo

Overview

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

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.

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 (e.g., FDA, ISO 13485, MDR, and IVDR)
• Establish, implement, review and update QMS procedures
• Implement CAPA process
• Participate in activities on Risk Management File
• Develop process validation protocols (IQ-OQ-PQ) and write summary reports
• 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
• Coordinate and collaborate with cross-functional teams, including Management, Operations, and Sales Team

Required 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
• V&V requirements
• Experience with post-market surveillance
• Technical skills related to medical device industry processes
• Strong analytical skills and ability to work in a structured and concise manner
• Effective written and verbal communication in English

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there\'s a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.