Job description

Risk Manager

Oxford

 Role Information

• Job Title: Risk Manager
• Employment Status: Part-Time or Full-Time, Permanent
• Practice: Systems
• Location: Oxford - hybrid 
• Salary: £45,000 - £60,000

Company:

Do you want to make a difference while advancing your career? Come join Osler.

We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.

We are now recruiting for a Risk Manager based in Oxford to plan and coordinate risk management throughout the product development lifecycle.

Join us and help build a better future.

Key Responsibilities:

• Plan and coordinate risk management activities in accordance with IVD regulatory standards, throughout the product development lifecycle​
• Create and maintain risk documentation within an ISO 13485 QMS across multiple projects and jurisdictions​
• Work collaboratively with QARA, R&D and Production to drive identification, analysis and control of product risks​
• Develop and manage a process for the identification and management of risks outside of regular risk-focused sessions​

Skills & Experience:

Essential

• Experience working within an ISO 13485 QMS in medical device / IVD product development​
• Experience leading and documenting product risk management processes, e.g., FMEA, FTA, Hazard Analysis, etc.​
• Coordination and facilitation across quality, regulatory and multi-disciplinary technical teams​
• Excellent written and spoken English, clear communication with all types of stakeholders​
• Highly competent in Word, Excel, PowerPoint, etc.​

Desirable

• Technical background in design, engineering, and/or biotechnology​
• In-depth knowledge of ISO 13485 / ISO 14971 regulatory requirements​
• Experience working within additional IVD / medical device regulatory frameworks, e.g., FDA (21 CFR Part 820, 21 CFR Part 11)

Benefits:

We offer a competitive benefits package, with a focus on health and well-being - further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.

• 25 days holiday + bank holidays and a Christmas closure
• Yearly Learning & Development budget 4% of your salary
• 12 days of Learning leave
• 4% matched pension
• £500 Well-being allowance
• Private Medical Insurance - (includes subsidised gym memberships)
• 24/7 access to a GP
• Life Assurance - x4 annual salary
• Income Protection - 75% of your basic annual salary
• Private Travel Insurance
• Annual eye tests
• Cycle to work scheme
• Travel to work loan scheme
• Relocation assistance
• Volunteering leave
• Give as you earn - pre-tax salary donations to any UK charitable organisation.
• Quarterly Team Building events and social events
• Enhanced maternity/paternity