QA/RA Manager (Medical Devices)
A fantastic opportunity has become available for a talented QA Manager to work for a growing and innovative Midlands based Medical Device Company. Operating out of their state of the art, UK based manufacturing site, this dynamic company have ambitious plans to become leaders within the field of Ophthalmic Medical Devices.
As the QA/RA Manager you will work as part of a small team and be responsible for day to day running of the Quality and Regulatory department. Using your experience and knowledge within the Medical Device sector, you will maintain the Quality Management system in place and oversee the Regulatory submissions as this company look to bring their Ophthalmic devices to new markets!
- To manage and maintain the work related to the functioning of the Quality System, in compliance with ISO 13485/9001
- Responsible for all Regulatory matters, including technical files, CE marking and overseas registration
- Monitoring supplier performance, inspection failures and customer complaints.
- Maintain and update the required documentation, including drawings and CAPAs.
- Allocation of projects/tasks, ensuring that every member of your team has a clear objective within a defined time frame.
- Liaise with corporate and external contacts with regards to Quality issues.
- Involved with Labeling, Packaging, Regulatory processes and validations.
- Excellent understanding of European Medical Device Directive requirements.
- Knowledgeable of: EN ISO 13485, ISO 9001, CMDCAS.
- A strong Regulatory background.
- Be Self-motivated and able to work independently or as part of a team
Ideally you should also have:
- Experience of managing Regulatory/Quality teams.
- Certified internal Auditor.
- Experience working with class IIa Medical Devices.
For the successful QA/RA Manager, the company are offering a competitive package, including a great pension scheme/private medical. This is a superb opportunity for a talented individual to take the next step up into management. The company would consider someone with a strong Regulatory background, looking to move into management where training could be offered on the Quality Management System!
If this is something that you would further details on, please contact Jack Lacy on +44 (0) 121 616 3467 for a confidential discussion, or alternatively email email@example.com
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