Regulatory Project Leader - Medical Devices

Date Posted: Friday, 17th of February 2012

Salary: Negotiable

Start Date: ASAP

Telephone: 01438 870024

Location: Blackpool

Consultant Name: Meera Pattni

Sector: Medical Devices

Description

Regulatory Project Leader

This is a maternity leave contract role for 12 - 18 months initially with the chance to become permanent. This role has 2 direct line management responsibilities, and responsibility for managing the department in^the absence of the Regulatory Affairs Manager.

Job purpose:
You will be responsible for effectively managing the registration of the Company’s products worldwide whether new product introductions or maintenance of existing registrations whilst maintaining complete regulatory compliance throughout.

Main responsibilities:
Supervise the regulatory function ensuring it fully supports the business objectives.
Establish and maintain good relationships with Regulatory Authorities, Regulatory colleagues and provide support to worldwide company colleagues.
Effectively manage worldwide registrations activities.
Ensure product approval and registration is obtained for all new products by ensuring that all new product^dossiers are created where appropriate in line with country requirements.
Drive effectiveregistration strategies to ensure regulatory programmes are standardised to obtain earliest possible approval.
Establish and maintain processes for the status and maintenance of registrations, interim notifications and period re-submissions.
Strategically work with New Product Development in the development of new products and technologies delivering first in class regulatory strategy for product commercialisation.
Ensure that the Company’s post marketing surveillance responsibilities arefulfilled and support vigilance activities.
Liaise with internal departments to provide regulatory direction, input and support.
Represent the Company to Regulatory Bodies and customers.
Maintain progress and development of worldwide regulatory environments, and to address regulatory requirements.
Implement preventative and corrective actions plan programmes as appropriate.

Person specification:
Life sciences degree is essential.
Regulatory experience within medical devices is preferred, but a pharmaceutical background will also be considered.
Excellent knowledge of worldwide regulatory procedures.
Life management experience desirable.
Knowledge of orthopaedic medical devices desirable.

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 CL23735 in all correspondence.

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