Job Description


Regulatory Affairs Officer


Job Requirements/Description
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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