A leading manufacture of medical devices has an exciting opportunity for a Senior Regulatory Affairs Officer to join a busy Regulatory Affairs Team in Glasgow. This is a varied and wide ranging role. Your main function will be to ensure the Regulatory Affairs team meet stated objectives and provide back up for other team members. In particular, the job role will involve coordination of the following activities:
• Ensuring compliance with CE marking and all other appropriate regulatory requirements
• Regulatory Registrations
• Risk Management
• Labelling
• Post Market Surveillance and Vigilance
• Clinical and Biological Evaluations
• Providing Regulatory input to Design and Process Change projects
Ideally you will have a Degree in Life / Biomedical Sciences or Chemistry. Recent experience in a supervisory Regulatory Affairs role and experience of working in an ISO 9001 or ISO 13485 Quality System environment is also required. Knowledge of medical devices would be advantageous. The ability to work to deadlines is essential; you will be a team player, enthusiastic, flexible, and reliable with excellent communication and organizational skills. Accuracy and attention to detail is a must.
Upto £35,000 + benefits

0121 616 5066




