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

Recruiter
Meet Recruitment Ltd
Location
Manchester
Salary
£35-40k
Posted
18 Mar 2017
Closes
17 Apr 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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.

Responsibilities:

- 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.

Meet are good people who are great at recruitment. We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at *************************** and **********************************-berkley-a25811139/

Key Words

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