A MedTech business based in Henley-on-Thames are looking to hire a specialist Regulatory Affairs Advisor to play a key role in ensuring the businesses products comply with national and international regulatory requirements.
This role is vital to the business and team and will work closely with the Managing Directors. The role will have a wide variety of responsibilities and day to day duties, some included are:
*Executing regulatory strategies for new as well as existing medical devices keeping in line with UK & international standards
*Submitting regulation filings to the relevant bodies
*Being the main point of contact for all aspects of regulation work
*Pulling together clinical support data & analysis
*Post market performance analysis work
*Labelling & documentation work
*Tender management & submissions
*Providing training & support to other internal members
With the importance of this position the business is seeking candidates with the following experience:
*Career experience within Regulatory Affairs in the MedTech / Life Sciences industry
*Medical devices focussed background
*Must have excellent knowledge of UKCA marking, MHRA, EU MDR, and FDA regulatory requirements.
*Must have excellent understanding of ISO 13485, ISO 14971, and relevant quality management systems.
*Preferable education to degree or masters level in a supporting field
*Additional Regulatory Affairs Certifications would be advantageous
*Exceptional written and verbal communication skills
*Highly organised
*Excellent at delivering training & support
*Hardworking
*Happy to commit to an office based role in Henley-on-Thames
The role is a Monday to Friday position with hours of 8:30am to 5:00pm and the business are ideally seeking to pay a salary dependent of experience between £35,000 to £45,000 per annum.
If this role sounds a great fit for you, please apply and we look forward to speaking with you soon.