Regulatory Affairs Associate – Medical Device Italy

Resourcing Life Science; Italia; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A life sciences recruitment firm is seeking a Regulatory Affairs professional with at least 4 years of experience in the medical device sector. The role involves conducting regulatory assessments, managing registrations, and supporting FDA submissions. Excellent communication and problem-solving skills are essential, along with fluency in English. If you are interested in this opportunity, please reach out for more details.

Competenze

• Minimum 4 years of experience in Regulatory Affairs in the medical device.
• Proven experience with global submissions, preferably including FDA.
• Fluent in English (written and spoken).

Mansioni

• Conduct regulatory impact assessments for product changes.
• Manage annual registrations and license renewals.
• Support preparation and submission of FDA dossiers.
• Coordinate data collection for regulatory registrations.
• Collaborate with global partners for compliant submissions.

Conoscenze

Regulatory assessments

Communication

Problem-solving

Global submissions

Formazione

Bachelor degree

Descrizione del lavoro

What to Expect

• Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
• Manage annual registrations, license renewals, and ongoing regulatory notifications.
• Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
• Coordinate the collection, review, and consolidation of data for international regulatory registrations.
• Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
• Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function.

Requirements

• Bachelor degree
• Min 4 years of experience in Regulatory Affairs in the medical device
• Proven experience with global submissions, preferably including FDA,
• Excellent communication and problem-solving skills
• Fluent in English (written and spoken).

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]