Owlstone Medical has developed a breathalyzer for the early detection of cancer, inflammatory and infectious disease. Our mission is to save 100,000 lives and $1.5B in healthcare costs. We need to add an experienced RA Manager to our team to help us achieve it.
About the Job:
The RA Manager is responsible for managing the companies Regulatory compliance in accordance with Company, International Regulatory and Customer requirements.
Responsibilities will include:
- Have a clear understanding of the requirements for EU and FDA regulatory compliance for medical devices and IVD diagnostics and provide advice and guidance to the business as required
- Maintenance of Regulatory requirements within the business to achieve ongoing compliance all regulatory requirements identified as a needed for the business.
- Monitoring and advising on global regulatory changes and any new requirements for the business and or specific medical device projects.
- Leading RA projects from idea to implementation and compliance,
- Provide training to employees on the Regulatory compliance requirements.
- Developing and implementing regulatory management strategies and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation’s annual business plan and long term strategy
- Liaise and co-operate with relevant Regulatory and Competent Authorities as required
- To maintain the complaints and vigilance system in accordance with all national and international regulatory requirements
- To co-ordinate all regulatory submissions for product approval with the relevant regulatory authorities or notified bodies
- Plan and manage departmental activities in accordance with agreed budgets and timescales
- To work closely with the QA team to ensure that all regulatory requirements are effectively addressed within the QMS
- Responsible for the maintenance of all device technical files and related regulatory submissions
- Report and detail any action required as necessary on changes in standards and regulations that could impact on device technical files and/or registrations.
- To ensure that ll changes to product are reviewed to ensure on going regulatory compliance
- Manage staff according to company standards (appraisals, training, development, etc)
- Manage departmental performance against agreed targets and budgets, and within policies and standards
- Reporting on the performance of the Regulatory system.
The successful candidate will have/be:
- Familiarity with regulatory the MDD 93/42/EEC and/or IVDD 98/79/EC
- Experience with construction of EU technical Files and FDA 510k submissions
- You must be highly organised, methodical with excellent attention to detail, possess excellent communication, influencing, Regulatory and PC skills.
- Minimum of 5 years’ experience as a Regulatory Assurance role either with Medical Devices or IVD’s
- Have the ability to work under pressure (individually and as part of a team), to effectively manage the workload to meet challenging deadlines whilst maintaining regulatory requirements within a dynamic commercial environment.
Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com. Every time you breathe out there are hundreds of chemicals on your breath – some are telltale markers of disease, which our microchip chemical sensor technology is able to detect. They key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage it drops to about 5% – unfortunately there are still far too many people detected at late stage.
The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Defence and Security.
We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes share options and your work will have a clear impact on patients’ lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone is the place for you.
To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to Reveal email address