Regulatory Affairs Specialist L.68 / 99

PQE Group; Firenze; Ibrido; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

PQE Group, a leader in the Pharmaceutical and Medical Device industries, seeks a Regulatory Affairs Specialist based in Florence, Italy. The role focuses on regulatory compliance, requiring a scientific background and expertise in international regulations. Join a multicultural team dedicated to innovation and collaboration, and take the next step in your career.

Servizi

International projects

Skill improvement opportunities

Collaborative work environment

Competenze

• 1-3 years of experience in regulatory field.
• Familiarity with European and international regulatory frameworks.
• Excellent analytical skills and teamwork.

Mansioni

• Execution of new registrations for product lines.
• Definition of regulatory strategies.
• Coordination of regulatory submissions.

Conoscenze

Analytical Skills

Teamwork

Regulatory Compliance

English Proficiency

Formazione

Bachelor's or Master's degree in a scientific field

Strumenti

Office Suite

SAP

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 in Europe, Asia and the Americas.

Following a new opportunity, we are currently looking for a Regulatory Affairs Specialist to support one of our clients in Florence, Italy .

You will be responsible for :

• Execution of new registrations for our various product lines;
• Definition of regulatory strategies in compliance with the regulations of the countries where we operate;
• Coordination of activities related to the preparation of documents and regulatory submissions;
• Communication and collaboration with regulatory consulting firms to plan pre-submission approaches, compliance testing requirements, and follow-up of submissions to ensure regulatory compliance;
• Compilation and maintenance of regulatory databases or documentation systems;
• Support for local regulatory teams and internal departments;
• Monitoring and interpretation of regulatory standards and their changes, to ensure correct communication through company policies and procedures;
• Support for regulatory inspections.

About you :

• 1-3 years of experience in the regulatory field, preferably in multinational or structured companies producing medical devices or pharmaceuticals;
• Bachelor's or Master's degree, preferably in a scientific field;
• Familiarity with the European and international regulatory framework (MDR, FDA Quality System Regulations, MDSAP);
• English language proficiency in speaking and writing (at least B2 level)
• Proficiency in the Office suite (knowledge of SAP would be a plus);
• Excellent analytical skills and ability to work in a team.

Location : Reggello, but with possibility to work full remote.

Next Steps

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