We specialise in the design, development and manufacture of complex medical devices for the world's leading pharmaceutical companies at low, medium and high-volume manufacturing scales. We are focused on continual product innovation for drug delivery devices production and have been dedicated to world-class design, industrialisation and reliable high-volume supply for over 50 years. 

Due to continued growth we have an exciting opportunity for a Regulatory Affairs Specialist to join our team. As our new Regulatory Affairs Specialist, you will be responsible for providing regulatory advice and information to support the design, development and commercialisation of products and the planning, supporting and executing the design and development stages and regulatory stages for New Product Introduction.

Essential Skills & Experience

• Knowledge of ISO 13485, ISO 14971 CFR 211 and 280 and Part 11 requirements.
• Proven experience within a Regulatory Affairs role in the Medical Device sector
• Demonstrable experience of regulatory requirements at various stages of the product life cycle. 
• Ability to work cross functionally and to influence different departments

This is a primarily site based position, however, there is flexibility of 1 to 2 days a week available .  

If you have the necessary skills and experience and want to join a company passionate about your career, click apply now or call 01189239234 and ask for Kris Holmes.