Regulatory Affairs Subject Matter Expert (SME)

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.

Job Overview

Due to our continuous growth, we are currently seeking a Regulatory Affairs Subject Matter Expert (SME) with extensive experience in consultancy to provide strategic guidance and compliance expertise in global regulatory submissions. The ideal candidate will advise clients on complex regulatory pathways, risk management, and post-market compliance while ensuring adherence to evolving regulations.

Key Responsibilities

EU Regulatory Strategy & Compliance

• Advise clients on EU MDR 2017/745, IVDR 2017/746, and other EU directives (e.g., REACH, CLP, GDPR).
• Develop and execute regulatory strategies for CE marking, technical documentation, and clinical evaluations.
• Conduct gap assessments and remediation plans for compliance with EU regulations.

Submissions & Notified Body Interactions

• Lead preparation and submission of Technical Documentation, Design Dossier, and Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 and MDR requirements.
• Manage CE marking processes, including interactions with Notified Bodies and Competent Authorities.
• Support EUDAMED registration and post-market surveillance (PMS, PMCF, vigilance reporting).

Audits & Regulatory Intelligence

• Perform compliance audits against ISO 13485, ISO 14971, and EU MDR/IVDR.
• Monitor and interpret new EU guidelines (e.g., MDCG, EMA updates) and advise clients on implementation.
• Represent clients in discussions with EMA, Notified Bodies, and National Competent Authorities (e.g., AIFA, BfArM).

Qualifications

• Education: Master’s degree in Pharmacy, Biotechnology, Biomedical Engineering, or related field.
• Experience:
• 10+ years in Regulatory Affairs, with a strong focus on EU regulations.
• Proven consulting background with hands-on experience in EU submissions (MDR/IVDR, EMA procedures).
• Technical Expertise:
• In-depth knowledge of EUDAMED, MDR/IVDR, Clinical Investigation Regulation (EU 2017/745), and MDCG guidance.
• Languages: Fluent in English and Italian; additional EU languages are a plus.
• Excellent written and oral communication skills.
• Certifications (Preferred): RAC (EU), ISO 13485 Lead Auditor.

Next Steps

Upon receiving your application, if a match is found, the Talent Acquisition 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 feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.