Regulatory Affairs Subject Matter Expert (SME)

Are you ready to join a world leader in the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront since 1998, with 40 subsidiaries and over 2000 employees across Europe, Asia, and the Americas.

Job Overview

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

Key Responsibilities

EU Regulatory Strategy & Compliance

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

Submissions & Notified Body Interactions

• Lead the preparation and submission of Technical Documentation, Design Dossiers, 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 activities (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

• Master’s degree in Pharmacy, Biotechnology, Biomedical Engineering, or related field.
• 10+ years in Regulatory Affairs, with a focus on EU regulations.
• Proven consulting experience with EU submissions (MDR/IVDR, EMA procedures).
• Technical expertise in EUDAMED, MDR/IVDR, EU Clinical Investigation Regulation (EU 2017/745), and MDCG guidance.
• Fluent in English and Italian; additional EU languages are a plus.
• Excellent communication skills, both written and oral.
• Certifications such as RAC (EU) and ISO 13485 Lead Auditor are preferred.

Next Steps

Upon application, the Talent Acquisition team will contact suitable candidates for an HR interview. Successful candidates will proceed to a technical interview with the Hiring Manager. Positive feedback will lead to further discussions or proposals. Negative feedback will be communicated to halt the process.

Working at PQE Group

Join a multicultural, collaborative, and innovative environment. PQE offers opportunities to work on international projects, enhance your skills, and connect with colleagues worldwide. If you seek a rewarding career, apply now and take the first step towards an exciting future with us.