Expertise in EU Regulatory Compliance

beBeeRegulatoryAffairs; Milano; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A regulatory affairs consultancy in Italy is seeking a Regulatory Affairs Expert to guide regulatory submissions and compliance. The ideal candidate will have over 10 years of experience in EU regulations, strong communication skills, and possess a Master's degree in a related field. The role involves strategic guidance in CE marking and regulatory compliance, contributing to international projects and collaboration.

Servizi

Opportunity to work on international projects

Skill development

Collaborate with worldwide colleagues

Competenze

• At least 10 years of experience in Regulatory Affairs with a focus on EU regulations.
• Fluent in English and Italian; additional EU languages are a plus.

Mansioni

• Develop and execute regulatory strategies for CE marking and clinical evaluations.
• Conduct gap assessments and compliance monitoring against EU regulations.

Conoscenze

Regulatory strategy development

Compliance monitoring

Gap assessments

Excellent communication

Formazione

Master's degree in Pharmacy, Biotechnology, Biomedical Engineering

Descrizione del lavoro

Regulatory Affairs Expert

We are seeking a highly skilled Regulatory Affairs Subject Matter Expert (SME) to provide strategic guidance and compliance expertise in global regulatory submissions.

• Duties and Responsibilities:
• Develop and execute regulatory strategies for CE marking, technical documentation, and clinical evaluations.
• Conduct gap assessments and remediation plans for compliance with EU regulations.
• Audit and perform compliance monitoring against ISO 13485, ISO 14971, and EU MDR / IVDR.

About the Role:

This role is ideal for candidates with extensive experience in consultancy, providing expert advice on complex regulatory pathways, risk management, and post-market compliance while ensuring adherence to evolving regulations.

Requirements:

• Educational Background: A Master's degree in Pharmacy, Biotechnology, Biomedical Engineering, or a related field.
• Professional Experience: At least 10 years of experience in Regulatory Affairs, with a strong focus on EU regulations.
• Languages: Fluent in English and Italian; additional EU languages are a plus.
• Skillset: Excellent written and oral communication skills.

What We Offer:

PQE Group offers the opportunity to work on international projects, develop your skills, and collaborate with colleagues worldwide. 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 follow.