regulatory affairs specialist in basingstoke

posted
job type
temporary
salary
£ 40,000 per year
apply now

job details

posted
location
basingstoke, south east
job category
production
job type
temporary
working hours
Full-Time
salary
£ 40,000 per year
reference number
A-RA-P-B
phone
07342 083989
apply now

job description

Do you have experience in a Regulatory Affairs role working on an MDR (Medical Device Regulations) Project?

Are you interested in working for a global leader in healthcare technology and have access to great benefits? If yes, please read on below!

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

Hours of Work and Salary:



* Monday - Friday (37.5 hours PER WEEK)

* 08:00AM to 16:00PM



* Salary negotiable based on experience

Opportunity to work from home 1 to 2 days per week.

This is a temporary role for a period of up to 5 months with the possibility of being extended.

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:



* Experience within the medical device industry in a regulatory affairs role.
* 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 today!