Regulatory Affairs Subject Matter Expert (SME)

PQE Group; Varese; In loco; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

An innovative company in the Pharmaceutical and Medical Device industry is seeking a Regulatory Affairs Subject Matter Expert (SME) to provide strategic regulatory guidance and compliance expertise for global submissions. Ideal candidates will possess a Master's degree and extensive experience in regulatory affairs focused on EU regulations. Responsibilities include advising clients, leading complex submissions, and conducting compliance audits. PQE Group offers a dynamic and collaborative working environment, ensuring career advancement and international exposure.

Competenze

• At least 10 years of experience in Regulatory Affairs with a focus on EU regulations.
• Proven consulting background with hands-on experience in EU submissions.
• Technical expertise in EUDAMED and MDR/IVDR regulations.

Mansioni

• Advise clients on EU MDR, IVDR, and other EU directives.
• Lead preparation and submission of Technical Documentation and Design Dossiers.
• Perform compliance audits against ISO 13485 and monitor new EU guidelines.

Conoscenze

Regulatory Affairs Expertise

Fluency in English

Fluency in Italian

Communication Skills

Formazione

Master’s Degree in Pharmacy, Biotechnology, or Biomedical Engineering

Descrizione del lavoro

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 across 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 consultancy experience 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, 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 develop remediation plans for compliance with EU regulations.

Submissions & Notified Body Interactions

• Lead 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 standards.
• Monitor and interpret new EU guidelines (e.g., MDCG, EMA updates) and advise clients on implementation strategies.
• 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.
• At least 10 years of experience 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 EUDAMED, MDR / IVDR, Clinical Investigation Regulation (EU 2017 / 745), and MDCG guidance.
• Fluent in English and Italian; additional EU languages are a plus.
• Excellent written and oral communication skills.
• Preferred certifications: RAC (EU), ISO 13485 Lead Auditor.

Next Steps

Upon receiving your application, our Talent Acquisition team will contact you for an initial HR interview. If a positive match is identified, a technical interview with the Hiring Manager will be scheduled. Successful candidates will be contacted for further steps or to discuss our offer. If not selected, we will inform you accordingly.

Working at PQE Group

As part of the PQE team, you will join a challenging, multicultural company that values collaboration and innovation. PQE Group offers opportunities to work on international projects, develop your skills, and interact with colleagues worldwide. If you seek a rewarding and exciting career, PQE Group is the ideal place for you. Apply now and take the first step towards an exciting future with us.