Regulatory & Scientific Affairs Specialist: Medical Devices

Stevanato Group; Liguria; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A growing healthcare organization in Italy is seeking a Regulatory & Scientific Affairs Specialist. The successful candidate will oversee the regulatory intelligence process and manage submissions to international regulatory agencies. Candidates should have 2-5 years of experience in the pharmaceutical or medical device industries, along with a Technical Master Degree and knowledge of applicable standards. This role offers the opportunity to work in a dynamic team environment where people are valued and empowered.

Competenze

• 2-5 years of experience in quality healthcare industries.
• Familiarity with FDA and Medical Device Regulations.
• Understanding of Quality Management Systems.

Mansioni

• Execute Regulatory Affairs strategy and provide feedback.
• Monitor regulatory requirements and assess relevant risks.
• Prepare necessary documents for regulatory approvals.
• Maintain accurate and up-to-date regulatory files.
• Collaborate with Compliance team and participate in audits.
• Monitor global regulations and participate in seminars.

Conoscenze

Experience with regulatory processes

Knowledge of ISO standards

Risk Management methodologies

Project Management skills

Formazione

Technical Master Degree

Descrizione del lavoro

A growing healthcare organization in Italy is seeking a Regulatory & Scientific Affairs Specialist. The successful candidate will oversee the regulatory intelligence process and manage submissions to international regulatory agencies. Candidates should have 2-5 years of experience in the pharmaceutical or medical device industries, along with a Technical Master Degree and knowledge of applicable standards. This role offers the opportunity to work in a dynamic team environment where people are valued and empowered.