Programme Manager – Medical Devices
Programme Manager – Medical Devices
Chandler's Ford, Hampshire
Do you have experience in CE-IVD or regulator certification for assays? Want to make a positive impact with a ground-breaking business as a Programme Manager? If so, our client wants to hear from you.
Born from modest beginnings, our client has grown from two guys with a great idea to a leading provider of RT PCR solutions. They have thousands of happy customers based across the globe and have a real ambition to drive their business forward and achieve even more.
Our client has ambitious growth plans and their Research & Development Team has doubled in size over the past three years. Now, they are looking for a Programme Manager to join them and take ownership of a portfolio of medical device CE marking schemes.
- Salary of up to £40,000
- Team lunches (they love to eat cake, so if you have a sweet tooth, you’ll be in good company)
- A personal trainer visits the office twice a week (so you can justify eating cake)
- Great summer and Christmas social events
- Pension scheme
- Life assurance
- 25 days’ holiday
Currently, the company are taking their first steps into the regulatory space, so you’ll have the chance to build the foundations of their validation process and make a lasting impact on their business.
Our client’s team are dedicated, and while they work hard, they like to have fun too. Their modern offices include a pool table, sofas and a coffee machine, so you’ll have lots of opportunities to unwind during work breaks.
As the Programme Manager, you will build, control and manage a portfolio of medical device CE marking schemes.
In this varied role, you’ll work with the R&D Team to plan and execute validation work in-line with regulatory directives.
Specifically, you will:
- Assess medical devices in-line with the ISO 13485 quality management system
- Provide specialist regulatory, operational and strategic support to colleagues
- Offer advice and guidance to junior team members
- Organise, review and evaluate medical device technical documentation
To be considered as a Programme Manager, you’ll need:
- Experience of being part of a successful CE-IVD or regulator certification for assays, preferably in genetic testing
- In-depth knowledge of the design and development of products, including the principles of design control, risk management and performance or clinical validation
- Knowledge of business processes and the application of quality management standards
- An understanding of the concepts and intent of product certification and service orientation
- A degree level qualification in a life sciences discipline
Experience in at least one of the following is also essential:
- Devices which incorporate medical applications
- Process validation
- Regulatory documentation
- Analytical methods
- Technology transfer
Our client is eager to hear from candidates with experience as a Medical Device Assessor, Medical Device Auditor, Product Validation Manager, Research and Development Project Lead / Manager, Medical Device Quality Manager or Product Quality Manager.
Webrecruit and our clients are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.
So, if you want to take your next step as a Programme Manager, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.