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Senior Regulatory Affairs Specialist

Manufacturing Jobs in Luton - Senior Regulatory Affairs Specialist

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    Full Time
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    pension + benefits
Job Description:

Regulatory Affairs Senior Specialist- Medical Devices
We are searching for an experienced Medical Device Regulatory Affairs professional to work as a Senior Regulatory Affairs Specialist for global registrations.
You will be joining an established medical device company who are highly regarded as a genuine market leader in their therapy areas with a particularly strong position in the European region.
For the incoming Regulatory Affairs person, this is an exciting time to join and play an integral role at a key time of growth for the business and up-skilling of the department. The Regulatory Affairs team will play a key role in leading on the continued commercial success of the business.
This Regulatory Affairs position is responsible for managing all facets of regulatory strategy to market, developing regulatory submissions for a broad product portfolio.
Duties and Responsibilities:
" The Senior Regulatory Affairs Specialist will be responsible for product registrations within Europe, Asia Pacific, Middle East & Africa, Central & Eastern Europe.
" Regulatory submissions for new and amended product license applications across a various of class of devices (up to but not including class III), within a broad product portfolio.
" Work closely with international affiliates, distributors and competent authorities to complete licence approvals to deadlines.
Candidate Requirements:
" You will need established experience of working with international medical device regulations.
" Detailed knowledge and practical application of international medical device regulations and pre-market registration requirements.
" Adaptability and the organizational skills to work with cross-functional teams.
" You must be able to interpret technical and clinical information to write accurate licence application documents.
If you are looking for an opportunity to shape work with a broad product portfolio and contribute to a growing company this is could be the role for you.
Please send your CV and contact James Powell of TXM Recruit.
("Regulatory affairs" OR "ce mark" OR "ce marking" OR "technical files" OR "design dossier" OR 93/42 OR mdd)
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.