Medical Devices Safety Ops Principal: Process Excellence Leader

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 120,000 - 170,000; Full time

Job summary

Roche is seeking a Principal for Medical Device safety operations to lead end-to-end case processing and process design across the global network. You will own post-market incident reporting and pre-market clinical investigation safety reporting, ensuring regulatory compliance and continuous improvement across the value chain.

The role requires you to oversee vendors, drive process improvements, and participate in audits and inspections while collaborating with Global Process Owners and

Qualifications

• Significant experience in pharmacovigilance or vigilance and business process management.
• Ability to lead cross-functional teams and manage complex process improvements.
• Knowledge of global regulatory obligations (ISO14155, MDR/IVDR) and audits.

Responsibilities

• Own end-to-end case processing for medical device safety reporting.
• Design, improve and ensure compliance of processes with regulatory guidelines.
• Oversee service providers and monitor case processing metrics/KPIs.
• Support AI-enabled safety data delivery and oversight activities.
• Represent case processing in audits and inspections across the network.

Skills

Strategic planning

Systems thinking

Agile leadership

Change management

Data governance

Global collaboration

Audits and inspections

AI in safety data

Stakeholder management

Decision making

Education

Degree in relevant field

Postgraduate degree in vigilance (PhD, PharmD, MSc, MD) preferred

Job description

Roche is seeking a Principal for Medical Device safety operations to lead end-to-end case processing and process design across the global network. You will own post-market incident reporting and pre-market clinical investigation safety reporting, ensuring regulatory compliance and continuous improvement across the value chain.

The role requires you to oversee vendors, drive process improvements, and participate in audits and inspections while collaborating with Global Process Owners and