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Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

Job Title: Senior Regulatory Affairs Associate
Contract Type: Contract
Location: Glasgow
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: CW-RA_1488221014
Contact Name: Catherine West
Contact Email: c.west@sciproglobal.com
Job Published: February 27, 2017 18:43

Job Description

Currently working with a Medical Device Company, who are seeking a Senior RA Associate to join their team for 12 months. This company is based in Glasgow, with adhoc homeworking as an option. Recent experience in a medical device company is essential.

Primary 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 activities
  • Production and review of design dossiers, technical files and device master files
  • Review and preparation of regulatory paperwork in accordance with International standards and new
  • regulations
  • 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
  • Other duties as required by RA department

Please get in contact about this opportunity by calling 02033273072 or email me at c.west@sciproglobal.com

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