Are you searching for a Regulatory Affairs role working on an MDR (Medical Device Regulations) Project ? Do you want to work at a global leader in healthcare technology and have access to great benefits? If yes, please read on below! Regulatory Affairs Officer role in Basingstoke, postcode RG23 8BG . Working on an MDR Project for a medical devices global leader. This is a temporary role for a period of up to 5 months with the possibility of being extended.
Benefits: • Flexible working • Competitive salary • Weekly pay • Access to Randstad benefits including high street discounts and wellbeing services • Clean office environment • Great transport links • 28 days holiday per year • Car park
Salary: Hours of work and Salary • Monday - Friday (37.5 hours per week) o 08:00AM to 16:00PM £40,000-£50,0000 pro rata - Negotiable based on experience Opportunity to work from home 1 to 2 days per week.
Responsibilities: This role will support the organisation in meeting regulatory obligations under the new EU Medical Device Regulation (MDR) 2017/745. Reporting to the Regulatory Affairs Manager, the main duties of the role will include but not be limited to the following; • Expert input into the organisation's MDR implementation plan • Working with key stakeholders to identify required changes to compliance processes and updating associated process documentation • Implementing improvements to technical files and clinical evaluation reports • Assessing the compliance position of medical device to international standards • Supporting the introduction of changes to the organization's risk management process • Improving medical device risk assessments with input from clinical and technical experts within the organization. Requirements: To be successful within this role you will be required to meet the below criteria: • 7+ years working within the medical device industry in a regulatory affairs role (permanent or temporary). • Strong scientific or engineering background. • Written presentation must be of high quality. • Work unsupervised under own initiative • Able to interpret authority regulations • Analytical • Desired - Experience working with active medical devices. • Desired - Experience in liaising with European notified bodies. • Desired - Knowledge of Medical Device Regulation (MDR) 2017/745
If this role is of interest to you and you feel that you meet the above criteria, please apply online or call Sophie on 07717 880 114 to discuss.