Regulatory Specialist - Oxfordshire

CK Clinical
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
Mary Bolt is recruiting for a Regulatory Specialist to join a diverse and innovative global pharmaceutical company at their site based in Oxfordshire on a contract basis.

The main purpose of the role will be to:
-Be responsible for implementing an efficient program to ensure that all EMEA registrations including Technical Files and country specific registration of products are achieved to an agreed schedule as well as working with the UK Regulatory affairs Manager to develop and implement strategies that will ensure the timely introduction of products onto the international market.
-Prepare complete and scientifically sound Regulatory submissions and implement the creation and development of Technical Files for both the IVD and Medical Device directives.
-Implement a roll out program for existing products and new launches and interact and work with country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure timely approval.

Further responsibilities will include:
-Reviewing all baseline labelling, marketing and training materials for Regulatory Compliance within EMEA.
-Providing timely guidance and support to project development teams to ensure project development and documentation will meet the regulatory requirements in target countries.
-Ensuring that all documentation is completed to a high standard and maintain awareness of regulations and guidelines governing the company and communicate their impact on the registrations.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in a Scientific, Engineering or related field with experience of working within Medical Device Regulatory Affairs.
-Experience in Regulatory Submissions for IVDs and/or Medical Devices and experience of working within the requirements of ISO13485, MD directive 93/42/EEC and IVD directive 98/79EC
-Strong organisational, analytical and communication skills.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 CL40528 in all correspondence.