£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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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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