Quality and Regulatory / QA Ra / Medical Device
Full job description
X4 Group Ltd
Salary: £36,000 – £42,000 per year
Position: Quality and Regulatory Officer / QA RA / Medical Device
Salary: £36,000 – £42,000
Location: London – North West
A Quality and Regulatory Officer / QA RA Associate is needed to join a Medical Device company based in London. This is a recognisable company who are well established within the ISO 13485 industry and they are looking for someone with a Quality and/or Regulatory background to join their team.
Management of ISO 13485 & ISO 9001 Quality Management System (including but not limited to)
– Development of new procedures as required
– Internal audits
– Second party supplier audits (overseas travel occasionally required)
– Post market surveillance
– Control of documents and changes
– Handling of complaints (customer and supplier)
– Management of approved suppliers file
– Packaging and artwork version control
– Traceability and batch numbers
– Design history of all new products
– Adverse event reporting
– Liaison with China office on ‘joint procedure projects’
– Document control (standards, directives, regulations etc.)
– Quality Management Representation
Creation and management of Technical Files for Class I, IIA and IIB Medical Devices (including but not limited to)
– Efficacy data
– Stability data
– Design history and design development
– Manufacturing instructions and procedures
– Risk Management
– Clinical evaluation
Key Skills: Quality/ QA / Regulatory / RA / ISO 13485 / ISO 9001 / Complaint / Customer / Technical File / DHF / Design History / CAPA / Deviation / Audit / Overseas
To apply for this job please visit definitejobs.co.uk.