Regulatory Affairs Specialist in Leeds

40,000 - 60,000
19 Nov 2018
17 Dec 2018
Regulatory Affairs
Contract Type
Mary Bolt is recruiting for a Regulatory Affairs Specialist to be based with a well known, global healthcare company with a varied portfolio of Medical Devices at their site based in Leeds on a contract basis.

The Company:
You will be working for a well known, global healthcare company with a varied portfolio of Medical Devices.

The Location:
The role is based at our client's site in Leeds which is easily commutable from most parts of Yorkshire as well as being within reach of Manchester. Leeds started as a medeival market town and now has the most diverse economy of all the UKs main employment centres. As well as the City, there are lots of historical parks and building as well as extensive green belt.

The Role:
The main purpose of the role will be to:
- Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches, inclusive of site transfer activities.
- Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers and guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Assist in the development of best practices for Regulatory Affairs processes.

Further responsibilities will include:
- Partnering with other functions to define and obtain data to assist with regulatory submissions and defining data and information needed for regulatory approvals.
- Developing labeling specifications and approving proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
- Providing Regulatory Affairs support during internal and external audits, planning schedules for regulatory deliverables on a project and monitoring project through completion as well as assisting in the development of best practices for Regulatory Affairs processes.

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 within life science or a related field with practical experience with the preparation of submissions for Class III medical devices (EU and USA).
- Relevant regulated industry experience is required with previous experience of working within Regulatory Affairs, substantial experience of US, EU and International Regulations  and experience with class II medical devices experience is also preferred.
- The ability to author and submit US, EU and International Regulatory submissions to Regulatory bodies as well as having tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products.

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 CL43968 in all correspondence.

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