Regulatory Affairs Subject Matter Expert (Sme)

Buscojobs; Emilia-Romagna; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading consultancy in pharmaceuticals is seeking a Regulatory Affairs Subject Matter Expert to provide strategic regulatory guidance and compliance expertise. You will advise clients on EU regulations, prepare documentation for submissions, and conduct audits. The ideal candidate has a master's degree and over 10 years of experience in Regulatory Affairs, focusing on EU regulations. Fluency in English and Italian is required, with other EU languages being a plus. Apply now for an exciting career in a multicultural environment.

Competenze

• 10+ years in Regulatory Affairs with focus on EU regulations.
• Proven record in EU submissions (MDR/IVDR).
• In-depth knowledge of EUDAMED, MDR/IVDR, Clinical Investigation Regulation.

Mansioni

• Advise clients on EU MDR 2017/745 and IVDR 2017/746 regulations.
• Lead preparation of Technical Documentation and Design Dossiers.
• Perform compliance audits against ISO standards.

Conoscenze

Regulatory compliance

Strategic guidance

Risk management

Consulting experience

Technical documentation

Clinical evaluations

Audit skills

Fluent in English

Fluent in Italian

Formazione

Master’s degree in Pharmacy, Biotechnology, Biomedical Engineering, or related field

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 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 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) in accordance with 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

• 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, our Talent Acquisition team will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be scheduled. Successful candidates will proceed to further steps or discussions about our offer. If not, we will inform you that the recruitment process has been halted.

Working at PQE Group

As part of the PQE team, you will be involved in a challenging, multicultural environment 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 toward an exciting future with us.