Role: Part Time Quality & Regulatory Affairs Coordinator
Location: North West London
Salary: £25K to £30K (Full Time) + excellent benefits, Part Time salary will be pro-rata.
Working Time: Part Time: approximately 24h / week, working days and hours are very flexible.
The Company
A highly successful 3D medical imaging company based in North West London providing patient positioning and monitoring solutions for radiotherapy.
Cancer is a common condition and a serious health problem, with more than one in three people likely to develop some form of cancer during their lifetime.
Radiotherapy is used to treat about half of all cancer patients. During radiotherapy, controlled doses of high-energy radiation destroy cancer cells in the affected area. Accurate positioning of the patient before each treatment and the monitoring of any motion throughout radiation delivery are required to ensure that the planned dose is correctly targeted on the cancer.
Vision RT is a world leader in the field of real time 3D surface imaging and has developed a revolutionary, market leading solution to the problems of patient setup and motion management. It works closely with scientific and clinical centres of excellence around the globe and has forged strong alliances with the major industry vendors. The Company is focused on the constant improvement of its proprietary technology and product range.
The Role:
The company is seeking an Quality & Regulatory Affairs Coordinator to provide administrative support for the planning, preparation and maintenance of quality documentation required by regulatory authorities.
Quality:
• Creating new quality procedures, and revising existing procedures with respect to the latest regulatory requirements.
• Revising the quality manual and procedures, to reflect changes and improvements in business processes.
• Coordinating the review and release of all controlled documents.
• Coordinating internal auditors to ensure that the Quality Audit Plan is completed on schedule.
• Recording Corrective and Preventative Actions and ensuring that they are closed out by assigned staff in a timely manner.
• Coordinating with department managers to collect and collate information for regular management reviews.
• Recording minutes, and actions from management review meetings and ensuring that they are completed by assigned staff in a timely manner.
• Coordinating external audits, and certificate renewals as required.
Regulatory:
• Monitoring regulatory changes and developments in the UK and current markets that impact the company
• Checking for new and revised standards and reviewing compliance with new mandatory standards.
• Maintaining regulatory documentation and preparing document submissions to regulatory bodies for product registration and clearance.
• Assisting in the maintenance of the Design History Files for all products.
• Collating and preparing product documents for submission for independent test facilities
• Work closely with all departments to ensure that any changes to products or packaging are made in line with regulatory requirements .
• Coordinating product labeling activities for all labeled materials including marketing materials
The Candidate:
Ideally, you will have 3 or more years experience in a similar role. You must also demonstrate the following skills:
• Ability to compose, review and revise complex technical quality and regulatory documents.
• Excell
