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Regulatory Affairs Officer

  • Fresh Jobs
  • Basingstoke
  • 10/02/2019
Full time

Job Description

Summary

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.