Regulatory Affairs Specialist – MedTech Devices

Alchimia Srl; Padova; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading medical device manufacturer in Padova is seeking a Regulatory Affairs Associate. This role involves managing international product registrations, ensuring compliance with relevant regulations, and maintaining technical documentation. The ideal candidate should have a degree in a scientific discipline and prior experience in Regulatory Affairs. Excellent English communication skills and attention to detail are essential. This position offers a dynamic working environment with opportunities for career growth.

Servizi

Meal vouchers

Welfare programs

Smart working options

Competenze

• Minimum 1 year experience in Regulatory Affairs or related roles in biomedical sectors.
• Knowledge of ISO standards and medical device regulations.
• Excellent command of English, both written and spoken.

Mansioni

• Manage international product registrations and documentation.
• Prepare technical files and ensure compliance with regulations.
• Support inspections by Notified Bodies related to product documentation.

Conoscenze

Regulatory compliance management

Analytical and problem-solving skills

Excellent written and verbal communication

Formazione

Degree in scientific discipline

Descrizione del lavoro

A leading medical device manufacturer in Padova is seeking a Regulatory Affairs Associate. This role involves managing international product registrations, ensuring compliance with relevant regulations, and maintaining technical documentation. The ideal candidate should have a degree in a scientific discipline and prior experience in Regulatory Affairs. Excellent English communication skills and attention to detail are essential. This position offers a dynamic working environment with opportunities for career growth.