Senior Medical Device Risk Engineer — ISO 14971 Expert

Vision RT Ltd; Basingstoke; Sur place; GBP 50 000 - 70 000; Plein temps

Résumé du poste

A leading MedTech company in Basingstoke is seeking a Senior Risk Management Engineer to enhance risk management practices for their medical devices. This full-time role involves creating Risk Management Files, conducting risk assessments, and supporting regulatory submissions. Ideal candidates will possess over 5 years of experience in risk management, knowledge of ISO standards, and excellent communication skills.

Qualifications

• 5+ years of risk management experience in regulated Class II or III medical device environments.
• Deep knowledge of ISO 14971, ISO/TR 24971, IEC 62304.
• Excellent communication skills to present complex risk concepts.

Responsabilités

• Lead the creation and maintenance of Risk Management Files according to ISO 14971.
• Conduct in-depth risk reviews based on post-market surveillance data.
• Support regulatory submissions and audits ensuring risk documentation is aligned with regulations.

Connaissances

Risk management experience

Knowledge of ISO 14971

Analytical skills

Communication skills

Proficiency with ALM tools

Organizational skills

Outils

Polarion

MatrixALM

DOORS

Enterprise Architect

Microsoft Office

Description du poste

A leading MedTech company in Basingstoke is seeking a Senior Risk Management Engineer to enhance risk management practices for their medical devices. This full-time role involves creating Risk Management Files, conducting risk assessments, and supporting regulatory submissions. Ideal candidates will possess over 5 years of experience in risk management, knowledge of ISO standards, and excellent communication skills.