Regulatory Affairs Associate

Regulatory Affairs Associate
  • £35,000 - £45,000 per Annum
  • Permanent
  • England, UK PL7 5BG UK PL7 5BG
Job Ref: J2157101
Sector: Science
Sub-sector: Medical Devices
Date Added: 15 September 2020
Regulatory Affairs Associate - Medical Device - Home Based

Regulatory Affairs Associate - Medical Device - Home Based SRG are currently recruiting for a RA Associate to join a SME Medical Device company who are looking for someone to join their growing team. The role will cover their European and US markets, and you'll be responsible for managing regulatory submissions in support of new product developments, and changes to our existing devices. You'll be liaising directly with regulatory authorities and be the point of contact for any queries.On a day-to-day basis, you can expect to be reviewing and approving documentation to support the submissions of regulatory documentation, along with advising on current, and future, Medical Device regulations to ensure compliance across the business.This will be a role that can be based remotely with occasional visits to thier manufacturing sites and HQ.What we're looking for?Degree, or equivalent qualification, in a Life Science, or equivalent industry experienceKnowledge of relevant GMP and Quality Systems standard, specifically with FDA Quality System Regulation and ISO 13485 relevant to this roleUnderstanding of the European Medical Devices Regulation (MDR) relevant to this roleExperience in preparation of and obtaining 510(k) clearance would be preferableExperience in preparation and obtaining Design Dossier approvals would be preferableExperience in maintaining technical filesExperience of working in a regulated environmentUnderstanding of Risk Management within a Medical Device industryAbility to query and analyse dataDemonstrated organisational skillsPlease apply or call Laith Mustafa on 0161 868 2231 for more details.

15/10/2020 13:46:57
GBP 35000 35000
Contact Consultant:
Laith Mustafa

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