Validation Manager, IVD/PoC/ISO13485 (Perm or FTC)
Osler has the potential to transform global health. It has built the foundation to do so and demonstrated that the vision can be realised. You will help realise this opportunity, shaping the direction of a rapidly scaling company, operating in a high-pace, visionary, intellectually rigorous, and (crucially) pragmatic environment, where you will be expected to be proactive, engage in debate, think strategically, and contribute towards our purpose to improve the lives of hundreds of millions of people.
Osler is a fast-growing healthcare company in the late stages of developing a versatile point-of-care in vitro diagnostic (IVD) platform. This will be Osler's first marketed product, requiring the development of supporting business processes in parallel with project execution. Planning and execution of appropriate Verification and Validation (V&V) processes and activities will be critical to Osler's success, and this role will drive V&V activities across the product development programme.
Scope of role
Direct the planning and execution of V&V activities across the product development programme;
- Design Verification testing, including all system and subsystem level verification testing according to FDA / IVDR requirements
- Design Validation testing, including clinical performance evaluation, working closely with Osler's contract research organisation (CRO) and clinical partners
- Manufacturing Process Validation, working closely with Osler's manufacturing team and contract manufacturing partners
This role requires hands-on knowledge and experience across the later stages of IVD medical device development. The successful candidate must demonstrate;
- The ability to develop compliant and efficient plans for delivering the Design Verification element of IVD medical device developments within an ISO 13485 certified QMS
- Awareness of the most recent FDA / IVDR requirements for Design Verification and Design Validation of IVD medical devices
- Manufacturing process validation for durable (instrumentation) and consumable (cartridges) medical devices
- A pragmatic approach to test method validation and sample size determination for standard and proprietary verification tests
- Experience of leading V&V activities for immunoassay and clinical chemistry assays
- Experience of implementing CLSI guidelines for the Analytical Validation of IVD assay performance
- Development and execution of processes and activities to satisfy FDA Computer System Validation requirements for IVD medical device development and manufacturing
OSLER WINNING BEHAVIOURS:
Courage Stepping up to address difficult issues, saying what needs to be said
Instill Trust Gaining the confidence and trust of others through honesty, integrity and authenticity
Nimble Learning Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder
Collaborate Building partnerships and working collaboratively with others to meet shared objectives
Action Orientated Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
Self Development Actively seeking new ways to grow and be challenged using both formal and informal development channels.
This is a rare opportunity to be at the cutting edge of new product development in a truly multidisciplinary environment where you can see the power and impact of your work to the end product. In order to create, not only something new, but a step-change in what we think is possible, we expect the best people, the do their best. Osler provide a fantastic platform for professional development including 12 days annually and 4% of your salary to your specific, personalised improvement. This is a special place where we encourage everyone to be entirely themselves in order to be your best self.
There is no perfect candidate and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.
We look forward to hearing from you and introducing you to Osler, thank you for taking the time to consider us and make your application.
Join us and build a better future.