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Regulatory Affairs Officer job in Swansea at Linea Resourcing Ltd

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Regulatory Affairs Officer at Linea Resourcing Ltd

Regulatory Affairs Officer

Linea Resourcing Ltd SA1, Swansea, City and County of Swansea, West Glamorgan Full-Time
£35,000/ year
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Opportunity to join a fast-paced SME medical device business and contribute to their on-going growth and development. The business has recently achieved numerous awards for their ground-breaking surgical products
The Role: The Regulatory Affairs Officer will play an important part at a key stage of the company’s growth and ensure compliance with regulatory requirements. Tasks will include:
* Prepare, submit and facilitate submissions in accordance with the appropriate regulatory body’s requirements
* Maintain each cleared filing following changes to product, process or labelling
* Liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues
* Offer general advice on regulatory strategy for new product developments, product re-development and process changes
* Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensure that these are compliant with the Quality Management System
* Monitor changes in legislation, standards and guidance documents
The Candidate: Regulatory Affairs Officer
* Ideally HNC / HND / Degree qualified in an engineering, medical or other relevant subject
* Previous experience gained as a Regulatory Affairs Officer (or similar)
* Experience preparing and submitting regulatory submissions to national regulators

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Job ID: 213058163


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