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Senior Regulatory Affairs Associate

Job Title: Senior Regulatory Affairs Associate
Contract Type: Permanent
Location: Inchinnan, Scotland
Industry:
Salary: Competitive
Start Date: 2019-08-19
Reference: BH-114179
Contact Name: Gregory Robertson
Contact Email: Gregory.Robertson@nesgt.com
Job Published: August 20, 2019 16:40

Job Description

Senior Regulatory Affairs Associate (Permanent Position)
My client, an established Medical Device company in Scotland are looking for experienced Regulatory Affairs Professionals to join them on a permanent basis.
Senior Regulatory Affairs Associate | Key Requirements:
  • 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 activities 
  • Production and review of design dossiers, technical files and change assessments 
  • Review and preparation of regulatory paperwork in accordance with International standards and new regulations 
  • Review Custom Made Device Technical File, and sign the Statement of Compliance on behalf of and in the absence/unavailability of Principal, Regulatory and Scientific Affairs 
  • Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations 
  • Facilitate compliance with Vigilance System 
  • Provide regulatory input to functional groups as required
  • Participate in review of RA procedures 
  • Review and approval of validation, protocols and reports 
  • Mentorship of RA Associates 
  • Facilitate in the compilation, communication and monitoring of FSN and recalls 
  • Other duties as required by RA department
 Senior Regulatory Affairs Associate | Key Requirements:
  • Educated to degree standard in a scientific or related subject
  • Regulatory experience within a medical device or pharmaceutical environment is essential
  • Confident communicating with external parties: Regulatory Authorities, Customers, Distributors, Notified Bodies, Competent Authorities 
  • Able to communicate with personnel in QA/R&D and other departments 
Senior Regulatory Affairs Associate | Other Details
  • 37 hour working week Monday to Thursday (8.30am to 17:00pm) Friday (8.30am – 13.30pm)
  • Company performance bonus scheme
  • Pension Scheme (6% contribution)
  • Holiday entitlement 33 days per annum