Regulatory Affairs Specialist - Somerset

Up to £50,000 per annum plus benefits - Regulatory Affairs
Ref: 21 Date Posted: Friday 06 Sep 2019
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Regulatory Affairs Specialist – Medical Devices

Somerset

Up to £50k

 

Our client is an established medical device company with a range of market leading medical devices sold globally.

 

They are an independent British medical device SME based in Somerset looking to secure a Regulatory Affairs Specialist.

 

This is an excellent opportunity to work in a progressive and broad regulatory affairs role offering a stable platform for career enhancement.

 

Job reference:

J-00160

 

Please apply today or contact Josh Craven at Indo Professional for more information. josh@indoprofessionals.co.uk / 01256 597 800

 

Position:

Regulatory Affairs Specialist – Medical Devices

 

Salary:

Up to £50,000 per annum plus benefits

 

Location:

Somerset – 1 hour from Bristol and commutable from Tiverton, Taunton, Exeter, Weston-Super-Mare, Yeovil, Bridgwater and surrounding areas

 

Job role:

This broad regulatory affairs position, the successful RA Specialist / Senior Regulatory Affairs Specialist position reports to the RA Manager focused on Class I, IIa & IIB medical devices. Responsibilities includes;

  • MDD to MDR transition
  • Risk Management
  • Clinical Evaluation Reports (CER)
  • Technical File management
  • Post market surveillance
  • New product introductions
  • Global product registrations – to over 50 countries
  • Liaison with Regulatory Competent authorities including MHRA, FDA, Health Canada
  • Assist with notified body audits

 

Ideal applicant:

Our client is looking for a Regulatory Affairs Specialist with proven medical device experience, further experience sought;

  • Ideally minimum of 2-5 years regulatory affairs experience within medical devices
  • Experience of medical device product registrations in multiple countries
  • Ideally US FDA 510(K) submissions experience – advantageous
  • Experience managing / updating technical files
  • ISO 14971 / risk management experience – advantageous
  • Excellent communication and presentation skills

 

Indo Professionals is a specialist staffing company focused on placing regulatory, quality and clinical research professionals. We work with our job seekers on a one to one basis providing full career consultation and assistance throughout the recruitment process. Please contact us today to discuss your next career challenge within med tech.