Regulatory Compliance Specialist — Medical Devices

Whatjobs; Busto Arsizio; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading laser technology company in Busto Arsizio is seeking a Regulatory Compliance Specialist. This role involves ensuring compliance of medical devices with regulatory standards. The ideal candidate will have a degree in scientific disciplines, experience in product compliance, and fluency in English and Italian. Strong attention to detail and project management skills are essential. Apply now for this exciting opportunity.

Competenze

• A strong grasp of EU Regulation 2017/745 (MDR) and Regulation (EU) 2022/2346.
• Knowledge of risk management standards such as ISO 14971.
• Proven experience in the medical device or healthcare industry as a technical writer.

Mansioni

• Identify compliance requirements for products and features.
• Cooperate with teams to ensure compliance during design development.
• Draft user manuals and create technical documentation for regulatory approval.
• Evaluate customer complaints for reportability.
• Collaborate during audits and regulatory body interactions.

Conoscenze

Fluency in written and spoken English

Fluency in written and spoken Italian

Strong writing and editing skills

Excellent project management skills

Strong attention to detail

Ability to work in a cross-functional team

Formazione

Degree in scientific disciplines

Minimum of 2 years work experience in product compliance

Strumenti

Adobe Illustrator

Descrizione del lavoro

A leading laser technology company in Busto Arsizio is seeking a Regulatory Compliance Specialist. This role involves ensuring compliance of medical devices with regulatory standards. The ideal candidate will have a degree in scientific disciplines, experience in product compliance, and fluency in English and Italian. Strong attention to detail and project management skills are essential. Apply now for this exciting opportunity.