Regulatory Affairs QMS Specialist

Regulatory compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as "Economic Operators" under the EU & UK MDR.

Device registration with UK MHRA with appropriate data added to the central database.

Client Details

Our client is a global brand focused on improving patients lives.

Description

Regulatory Affairs QMS Specialist is responsible for:

• Regulatory compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as "Economic Operators" under the EU & UK MDR.
• Device registration with UK MHRA with appropriate data added to the central database.
• Managing the verification role on behalf of our client's affiliates acting as Importers & Distributors, using company databases, enterprise resource planning (ERP) systems and liaising with manufacturers to ensure the correct data is available
• Liaison with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas
• General compliance with regulatory requirements including the MDR and those resulting from Brexit (e.g. UK MDR); liaison with Competent Authorities

Profile

We are looking for a Freelance Regulatory Affairs Specialist with several years experience in Regulatory Affairs including up to date experience or recent exposure to the UK/EU MDR requirements for Medical Device distribution.

Any experience in QMS/ audit is desirable but not essential.

Job Offer

On offer is a competitive rate and long term contract for 12 months.

Possible temp to perm.

Start in January, based in Basingstoke

Search Tags:

Freelance Regulatory Affairs Specialist

Regulatory Compliance

Medical Devices

QMS

Quality Management Systems Audit

UK MDR

EU MDR

ISO 13485, ISO 9001

Contract Position