Senior Technical Reviewer, Active Medical Devices

BSI; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A premier certification body is seeking a home-based Technical Specialist & Scheme Manager to evaluate medical devices for compliance and support manufacturers throughout their certification life cycle. The position requires at least 5 years of experience with active medical devices, a relevant degree, and a deep understanding of regulatory requirements. This role offers a competitive reward package along with flexible working hours and ongoing training in a dynamic international environment.

Servizi

Competitive total reward package

Flexible working hours

Ongoing training and development

Competenze

• A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
• Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use.
• Thorough knowledge of Medical Device regulation, including IEC 60601 Third Edition and ISO 14971.
• Understanding of design control and risk management principles.

Mansioni

• Review and evaluate medical device documentation for compliance.
• Manage certification activities for medical device manufacturers.
• Provide regulatory and operational support to the business.
• Lead and mentor medical devices personnel.

Conoscenze

Design and development experience

Research and development experience

Testing experience

Strong interpersonal communication skills

Ability to prioritize and execute workload

Formazione

Bachelor’s degree in relevant discipline

Strumenti

Regulatory expertise

Descrizione del lavoro

A premier certification body is seeking a home-based Technical Specialist & Scheme Manager to evaluate medical devices for compliance and support manufacturers throughout their certification life cycle. The position requires at least 5 years of experience with active medical devices, a relevant degree, and a deep understanding of regulatory requirements. This role offers a competitive reward package along with flexible working hours and ongoing training in a dynamic international environment.