Global AI-Driven Medical Device Safety Operations Lead

Roche Holding AG; Welwyn; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche Holding AG is seeking a senior safety operations professional to lead the intake, processing, and submission of ICSR and medical device safety reports. You will oversee global performance, drive process improvements, and champion AI-augmented workflows across a worldwide footprint.

We value a strategic, tech-forward mindset with strong leadership, regulatory knowledge, and the ability to influence stakeholders in a complex, matrixed environment.

Qualifications

• Degree in a relevant field; postgraduate qualification strongly desired.
• Minimum 3 years of industry experience in medical device vigilance and pharmacovigilance.
• Strong understanding of global safety obligations and medical device regulations (ISO 14155, ISO 20916, 21 CFR Part 812/820, EU MDR, EU IVDR).
• Proven leadership, project management, vendor oversight, and stakeholder influence across complex organisations.
• Tech-forward mindset with interest in AI for safety data delivery.

Responsibilities

• Drive operational excellence: oversight of ICSR and medical device safety report processing to ensure compliance and quality.
• Oversee global performance and vendors: monitor workload, quality, KPIs, and drive process improvements.
• Lead complex projects and process innovation: drive improvements and contribute to automation and AI innovations.
• Manage regulatory and legislative change: assess impact of new safety legislation and lead adaptations and training.
• Collaborate globally: build cross-functional networks and act as SME for safety case processing governance.

Skills

Strategic leadership

Cross-functional collaboration

Agile leadership

Innovation mindset

Education

Postgraduate degree or PV qualification

Job description

Roche Holding AG is seeking a senior safety operations professional to lead the intake, processing, and submission of ICSR and medical device safety reports. You will oversee global performance, drive process improvements, and champion AI-augmented workflows across a worldwide footprint.

We value a strategic, tech-forward mindset with strong leadership, regulatory knowledge, and the ability to influence stakeholders in a complex, matrixed environment.