Reference Number: JO-1908-435731
Associate Manager Regulatory Affairs
Job Type: Permanent
Associate Manager – Regulatory Affairs – Medical Devices
Maidenhead Office Based
Regulatory Professionals are currently collaborating with a rapidly growing clinical research organisation whose focus is within clinical and drug development across the globe. You will be joining a passionate team of dedicated employees who are committed in making a difference and strive to innovate and transform the drug development process.
The key role responsibilities will include:
Responsible for UK product registrations
Identifies and reports new or changed regulations
Supports commercial organization with the required Regulatory Documentation
Supports product notification in EU countries
Acts as EU Regulatory backup
Responsible for vigilance reporting of medical device incidents (MDI) and Field Safety Corrective Actions (FSCA) and related correspondence to UK competent authorities
The essential qualifications and/or experience required for this position are:
Solid scientific background (Degree in Medicine, Biology, Chemistry or Similar)
Demonstrated experience in regulatory affairs in the diagnostic/medical device industry, ideally with experience of In Vitro Diagnostics
Experience to work in an international work environment or on international projects is required
Project management and negotiation skills
Ability to work independently
Proficient in English
Knowledge of PC- and internet-based applications
If you are interested in discussing this position further then please send your CV to firstname.lastname@example.org or if you have any questions regarding the role then please call 01189 522 797.
Please note you must be eligible to work in the UK to be considered for this role.
If this role is not quite right for you, but youre interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if successfully placed, youll receive 250 worth of vouchers.