Company: Regulatory Professionals
Closing Date: 11 Feb 17
Type: Full Time
Salary (£): On Application
Senior Regulatory Affairs Associate - Devices Salary -£35,000-£39,000 pa Permanent - 37 hours pw Location - Oxfordshire Do you want to work for well-established company with over 70 years' experience?
Senior Regulatory Affairs Associate - Devices
Salary -£35,000-£39,000 pa
Permanent - 37 hours pw
Location - Oxfordshire
Do you want to work for well-established company with over 70 years' experience?
Would you like to work a world class Medical Device Company?
Are you looking to be a part of a business which truly believes in company values and employee relations?
Our client, a world-class Medical Device company is seeking an experienced and motivated Senior Regulatory Associate to support regulatory compliance and product registrations within 90 countries throughout the globe. In return the company are offering a competitive salary and commitment to developing employees within the organisation to advance their career within the Medical Device sector.
* Maintain, track and implement Regulatory compliance
* Provide, prepare and coordinate maintenance of technical documentation
* Provide documentation for product registrations including UDI for US and Global and for on-market changes
* Coordinate product field corrective actions, product risk management processes and the Post Market Surveillance Process
* Provide summary regulatory information for PMS
* Support the investigation of product complaints
* Participate at a department level in the operation of the Quality Management System
* Review the status of CAPAs
* Participate, support and follow up internal audits
* Provide quality assurance & regulatory affairs requirements and approvals
- Minimum 4 years of experience in regulatory affairs class II medical devices and compiling technical files
- Essential knowledge of USA FDA QMS, ISO 9001, 13485, Medical Devices Directive, application to Post Market Vigilance
- Life science graduate is essential
- Knowledge of another European language is a bonus
Keywords: Regulatory Affairs Senior Associate, Associate, Officer, Regulatory Affairs Senior Officer, medical devices, Oxford, class II, post approval, CAP, ISO 13485, ISO 9001, Oxfordshire, Oxford
3rd floor 33 Blagrave Street Reading
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