Regulatory Affairs Specialist - Part Time

Date Posted: Monday, 6th of February 2012

Salary: £25 p/h

Start Date: ASAP

Telephone: 01438 870024

Location: Livingston

Consultant Name: Meera Pattni

Sector: Medical Devices

Description

Regulatory Affairs Specialist - Medical Devices

Job purpose:
You will be responsible for providing a service to the international affiliates worldwide to enable them to register products from three business units. The role willinvolve ensuring that relevant data is identified and supplied allowing regulatory submissions to be made on time. The specialist will maintain an up to date knowledge of the regulatory environment and will also be responsible for regulatory approvalfor release of products.

Main responsibilities:
Respond to requests for information to register, update or renew approval for medical devices in International Markets (excluding USA and EU), with a particular focus on the Middle East.
Maintain records of requests and responses.
Obtaining Certificates of Free Sale from relevant health authorities and arranging notarisation and legislation of documents.
Ensuring that documents on the International Registration Sharepoint site are^complete and up to date.
Regulatory review of forms to release products to International Markets from the European Distribution Centre.
Understanding and keeping up to date with regulations relevant to Medical Devices in International Markets.

Person specification:
Life sciences degree essential.
Knowledge of device regulations essential.
Experience within regulatory affairs preferred.
Excellent communication and team work skills.
Ability to handle multiple and competing priorities.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23629 in all correspondence.

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