Patient Safety Operations Lead - Medical Devices

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

In Patient Safety Central Operations, we drive the intake, processing, and submission of device safety reports and Individual Case Safety Reports (ICSRs). In this role, you will lead operational oversight, foster innovation through AI-augmented workflows, and ensure high-quality safety data outputs across a global footprint.

Whilst our team manages safety reports for both medical devices and medicinal products, the successful candidate will focus primarily on medical devices.

Key Responsibilities:

• Drive Operational Excellence: Lead the 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 (e.g., EU MDR/IVDR, FDA regulations) 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.

Who You Are

You are a strategic, visionary safety professional with a passion for innovation, process optimization, and medical device vigilance. You thrive in agile, global matrix environments and excel at leading cross-functional teams without direct line authority.

Qualifications & Experience:

• Education: Degree in a relevant field (Postgraduate degree like PhD, PharmD, MSc, MD, or PV qualification strongly desired).

• Industry Experience: Minimum 3 years of industry experience, with a strong focus on medical device vigilance and pharmacovigilance operations.

• Regulatory Knowledge: Solid understanding of global safety obligations and medical device regulations, including ISO 14155, ISO 20916, 21 CFR Part 812/820, EU MDR (2017/745), and EU IVDR (2017/746).

• Leadership & Influence: Proven track record in project management, vendor oversight, agile squad leadership, and influencing stakeholders across complex organizations.

• Tech-Forward Mindset: Experience or strong interest in leveraging emerging technologies, such as Artificial Intelligence, for safety data delivery and quality oversight.

At Roche, we embrace emerging innovations, like AI, to enhance the patient journey. If you’re passionate about new technology and thinking ahead, we want you to join us!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.