£35000 - £45000 per annum + Additional Company Benefits;
A MedTech business based in Henley-on-Thames is looking to hire a specialist Regulatory Affairs Advisor to play a key role in ensuring the business's 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
* 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 focused 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 master's level in a supporting field
* Additional Regulatory Affairs Certifications would be advantageous
* Exceptional written and verbal communication skills
* Highly organised
* Hardworking
* Happy to commit to an office-based role in Henley-on-Thames
The role is a Monday to Friday position with hours of 8:30 am to 5:00 pm and the business is ideally seeking to pay a salary dependent on experience between £35,000 to £45,000 per annum.
If this role sounds like a great fit for you, please apply and we look forward to speaking with you soon.
Job Information
Job Reference: DB584_1733867360
Salary From: £35000
Salary To: £45000
Job Industries: Science and Research
Job Locations: Henley-On-Thames, Oxfordshire
Job Types: Full-time, Office Based, Permanent
Job Skills: Compliance, EU MDR, FDA, Henley-on-Thames, ISO 13485, ISO 14971, Life Science, MedTech, MHRA, Office Based, Permanent, Regulatory Affairs Advisor, UKCA Marking
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