Senior Regulatory Affairs Associate

Job Ref: J27339
Sector: Clinical
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 27 June 2018
  • Glasgow, Scotland, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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The Role:To carry out day to day regulatory tasks as required to ensure Regulatory compliance whilst working towards meeting quality objectives as stated within Quality systems.Key Responsibilities:Preparation of regulatory documentation and submissions for product approvals.Development of regulatory plans/strategies for new products and changes to existing products Participation in Design Control, Risk Management and Post Market Surveillance activitiesProduction and review of design dossiers, technical files and change assessmentsReview and preparation of regulatory paperwork in accordance with International standards and new regulationsReview of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulationsFacilitate compliance with Vigilance System.Skills/Experience Required:BSc DegreeExtensive experience working to Medical Device Directive and relevant standardsHands on experience within Regulatory Affairs in a Medical Devices background.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

27/07/2018 14:05:04