Quality and Regulatory Manager (Medical Devices)

X4 Group ,
Slough, Berkshire
More Details
Salary: £40k - 60k per year

Overview

This role will be to ensure that the company supplies quality products and operates within the legislative requirements applicable to IVD manufacture and distribution in line with ISO 13485 & IVDD To ensure activities meet with, and integrate with, company requirements for quality management, legal stipulations, environmental policies and general duty of care. You will need to be available with a 1 months’ notice or less to be considered for the opportunity as the company need someone to join the team ASAP. A permanent position paying between £40,000 and £60,000 per annum depending on experience. RESPONSIBILITIES: Quality To ensure that the company aims to supply defect free products fit for the purpose intended To ensure that the Quality System is fully documented, implemented, maintained and compliant with ISO 13485 on the appropriate software To review CAPA & Complaints records at appropriate meetings To ensure that all test and inspection parameters used during manufacture are identified and validated To report to Managing Director in the monthly meetings on the effectiveness of the Quality managements system and any need for improvement To ensure the promotion of awareness of applicable regulatory requirements and Quality management system requirements throughout the organization Regulatory Affairs To ensure that the company’s products and services are based on national and international regulatory requirements for manufacturing and distribution in all countries where the company requires these activities. This includes responsibility for ensuring compliance of the quality system with the EU IVDD Directive To ensure that the Device Master file and Device History files are maintained on appropriate software provided To manage Global compliance of all Subsidiaries and Distributors - in conjunction with Commercial Dept. To oversee the group wide External and Internal Audit programs, including SGS, FDA, and other national regulatory bodies. To ensure that issues regarding registration of products are resolved To ensure that the process to notify the relevant authorities / customers are in place via the change control systems To ensure all technical files are maintained and up to date Why Should You Apply? This is a very rare opportunity for someone to work in a small team in a very hands on position as the company grows from strength to strength taking on some of the giants of the Medical Device and IVD industries. Interviews will take place next week so if you are interested, do not hesitate in applying to Jack Lundgren at X4 Life Sciences and call on to discuss further. This will be a quick turnaround so please do get in touch. About Me: If this role isn't what you're looking for don't worry, I have over 3 years’ experience matching talent to the brilliant businesses they deserve in the Quality and Regulatory market and I am working with a number of really exciting clients currently. Please apply via the link if you believe you are suited to this position or you can get in touch with me directly and I can run though all my current vacancies within Quality & Regulatory. You will find me on LinkedIn – Jack Lundgren, X4 Life Sciences Alternatively, with 10 years’ experience here at X4 Life Sciences we cover all permanent and contract positions, with specialist industry sector teams. You can check out all of our roles on our website and sign up for job alerts so you are the first to know about a new opportunity. This job was originally posted as www.totaljobs.com/job/89918576

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