Regulatory Registration Administration Officer

Salary: £33,600 – £34,800 per year

We are working for our client who are a leading medical and pharmaceutical manufacturer in the search for a registration officer / administrator this role would suit someone with experience in high level administration and dealing with strict regulations ideally in a medical setting.

Responsibilities:

• Advise on country requirements with regards to changes in regulatory reporting requirements for medical devices and ensure that processes are kept up-to-date.
• Assist in meeting regulatory reporting obligations – when applicable – by liaising with relevant bodies and working with colleagues to progress the investigation and to keep all informed and updated as required.
• Ensure SOP’s for these areas are correct at all times
• Working knowledge of 93/42/EEC and 510(k) process (Advantageous)
• Collate technical information for use in regulatory registrations.
• Prepare and submit regulatory registration applications
• Ensure all registration information is logged into system
• Liaise with the Quality department on aspects of quality related documentation where required.
• Work alongside NPD and Regulatory team to create technical documentation in support of registrations, if required.

The Person

• Knowledge of working to strict regulations
• Medical experience advantageous
• Good communication and IT skills
• Used to multi tasking and working high level administration tasks
• Able to undertake training

Benefits:

• Permanent Full time position
• Training given
• Professional development and progression opportunities