• Back To Search
• Quick Apply
• Register Now
• Send Me More Jobs Like This

• Bedford
• Posted 9th Sep 2010
• Posted by: Austin Fraser Ltd
• Salary: GBP per annum + pension+phone+laptop+benefits
• Job Type: Permanent
• Reference: 2732278
• This job has been viewed 64 times since it was posted.

Job Description

Austin Fraser is currently recruiting for a Regulatory Affairs Manager to work for our client based in Bedfordshire. The function of the business is to rapidly design, develop, test and transfer to production, world class point of care testing solutions for over the counter home use. The firm is outstanding in both areas of Research and Development, Design and Engineering, New Product Development, Regulatory Affairs, Instrumentation, Compliance and Quality Assurance, Project Management, Finance and People and Organisational Development. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance of current products and registration of new products throughout the countries that business is conducted in and will need to be knowledgeable in the application of the MDD 93/42/EEC and FDA QSR 21 CFR part 82 regulations. Key requirements for this role: * Previous Medical Devices experience * Experience in the application of MDD 93/42/EEC and FDA QSR 21 CFR part 82 regulations * Computer Literate * Learn and understand new and previously unseen regulations * Experience in managing people * Ability to communicate on all levels including external government officials from different cultures * Good organisational skills * Qualified to degree level in a technical discipline or equivalent Our client offers outstanding career progression and salary. Please apply to this vacancy now as our client is moving fast on this role and is looking to fill someone in the position as soon as possible.