Regulatory Affairs Officer Oxfordshire Excellent Salaries 37.5 Hours - Flexitime Relocation Allowance A specialist manufacture of Medical Devices in the Oxford area is expanding throughout 2020.
As part of their growth, they require the skills of an additional Regulatory Affairs Officer.
The role will be responsible for arranging and managing licences for the assembly of drug products, meeting requirements of the MHRA, FDA and the Home Office.
The Role As a Regulatory Affairs Officer, you'll be: Responsible for developing and coordinating programs to ensure all international registrations and licences are completed efficiently.
Manage the creation and development of technical files.
Assure continued compliance with regulatory requirements to maintain applicable certifications.
Review proposed marketing materials, packaging, instructions for Regulatory Compliance to Annex I for CE Marked devices.
Your skills and experience: Proven experience of drug device combination regulatory strategies and submissions Experience in drug submission creation or drug submission support MDD (93/42/EEC) or IVD Directive (98/79/EC) Regulatory Submission for medical devices Auditing 13485 or 14971 Class I, II, III Medical devices The Company This is a great opportunity for a Regulatory Affairs Officer to join an ambitious manufacturing organisation who have committed their future to the UK.
You'll be part of a growing business that employs and ethos of continuous improvement for their employees and the wider organisation.
The Package In return you'll be offered a competitive package and generous benefits package.
Interviews will be taking place immediately, so please apply.
JAM Recruitment is acting as an employment agency with regards to this position.
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