Regulatory Affairs Specialist - Manchester - £35-40k - IVDs, MedDev

Meet Recruitment Ltd
18 Mar 2017
17 Apr 2017
Contract Type
Full Time
My client is a global Diagnostics company seeking a Regulatory Affairs Specialist to provide regulatory support to the business. This will be achieved by them operating as a member of the RA team with a mandate to promote a regulatory sound business practice and support the continuous improvement ethic throughout the organisation.

RA Specialist, £35-40k, Manchester, IVDs, Medical Devices

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.


- Identify and implement continuous process improvement projects, methodologies and tools to effect efficiency change and associated cost reductions / lean.
- As voice of the Customer; ensure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality Policy.
- Tracking regulatory changes (standards / directives).
- Contact as appropriate with regulatory authorities.
- To participate at a department level the operation of the Quality Management System as defined in Standard Operating Procedures and the associated Departmental Procedures, Work Instructions & Regulatory documents.
- Non-conformity/CAPA System
- Work with QA & RA teams to review the status of CAPAs
- Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.)
- Coordinate the technical file maintenance plans
- To maintain an awareness of the company's external regulatory contacts and define sources of information appropriate for performing key tasks.
- Maintenance of site establishment registrations and device listings & maintain regulatory database
- Provide documentation for product registrations including UDI for US and Global
- Produce documentation for on-market changes
- Coordinate the Post Market Surveillance Process
- Support and coordinate with the Director QARA in the risk evaluation program and Field correction process
- Provide input into the investigation of any serious product complaint relating to a product failure brought to our attention.
- Coordinate with the Director QARA any required field corrective action, where required, whether this is a Field Safety Corrective Action or a field advisory notice.

Essential experience:

- Minimum 4 years experience in Medical Device Regulatory Affairs / Quality Assurance
- Previous experience of involvement in key projects
- Essential knowledge of USA FDA QMS, ISO 9001, 13485, Medical Devices Directive, application to Post Market Vigilance (Product Complaints and Recalls) and associated MedDev guidelines.
- Experience of company representation at country level meetings
- Experience in vigilance reporting & communications with regulatory bodies and authorities
- Internal auditor trained

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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Key Words

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