Global AI-Driven Medical Device Safety Operations Lead

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

Job summary

Roche is seeking a strategic safety professional to lead the operational oversight of ICSRs and medical device safety reporting on a global scale. You will drive quality, compliance, and regulatory alignment while exploring AI-driven workflows to enhance data delivery and efficiency.

In a matrix, cross-functional environment, you will manage complex projects, oversee vendors, and navigate EU MDR/IVDR and FDA requirements, influencing stakeholders and guiding process improvements across the value

Qualifications

• 3+ years of industry experience in medical device vigilance and pharmacovigilance operations.
• Solid understanding of global safety obligations and medical device regulations (ISO 14155, ISO 20916, 21 CFR Part 812/820, EU MDR/IVDR).
• Proven leadership, project management, and cross-functional influence across complex organisations.

Responsibilities

• Drive Operational Excellence: Oversight of ICSR and medical device safety report processing to ensure compliance, quality, and alignment with regulatory standards and internal scientific requirements.
• Oversee Global Performance & Vendors: Monitor workload, quality, and KPIs across global footprint and vendor partnerships, driving inspection readiness and continuous process improvement.
• Lead Complex Projects & Process Innovation: Lead process improvements, and contribute to automation and AI innovations.
• Manage Regulatory & Legislative Change: Impact-assess revised safety legislation and lead process adaptations and training across the value chain.
• Collaborate Globally: Build strong cross-functional networks across global teams, acting as a Subject Matter Expert and escalation point for safety case processing governance.

Skills

Leadership & Influence

Regulatory Knowledge

Industry Experience

Tech-Forward Mindset

Collaboration

Education

Degree in a relevant field (with Postgraduate preferred)

Job description

Roche is seeking a strategic safety professional to lead the operational oversight of ICSRs and medical device safety reporting on a global scale. You will drive quality, compliance, and regulatory alignment while exploring AI-driven workflows to enhance data delivery and efficiency.

In a matrix, cross-functional environment, you will manage complex projects, oversee vendors, and navigate EU MDR/IVDR and FDA requirements, influencing stakeholders and guiding process improvements across the value