Regulatory Affairs Manager (IVD) – Lead EU Submissions

Arevna; Cambridge; Presencial; GBP 60.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary package

10% non-contributory pension

Group life assurance & income protection

25 days annual leave plus UK bank holidays

Descripción de la vacante

A pioneering life sciences organization in Cambridge is seeking a Regulatory Affairs Manager to lead regulatory strategy and execution throughout the product lifecycle. The role involves managing submissions, overseeing post-market activities, and mentoring junior talent. Candidates should have over 5 years of experience in regulatory affairs, particularly in IVD or medical devices. A competitive salary package and benefits are on offer.

Formación

• 5+ years’ experience in IVD and/or medical device regulatory affairs.
• Strong knowledge of ISO 13485 and ability to manage multiple projects.
• Recognised qualification in Regulatory Affairs.

Responsabilidades

• Lead the design and delivery of regulatory strategies.
• Manage submissions and global regulatory interactions.
• Oversee post-market activities including vigilance and recalls.

Conocimientos

Regulatory strategy

Cross-functional team collaboration

Project management

ISO 13485 compliance

Educación

Degree in life sciences

Descripción del empleo

A pioneering life sciences organization in Cambridge is seeking a Regulatory Affairs Manager to lead regulatory strategy and execution throughout the product lifecycle. The role involves managing submissions, overseeing post-market activities, and mentoring junior talent. Candidates should have over 5 years of experience in regulatory affairs, particularly in IVD or medical devices. A competitive salary package and benefits are on offer.