Senior Regulatory Affairs Associate, Jobs, Scotland, Glasgow, 5330

Engineering, Manufacturing & Supply Chain Recruitment

This vacancy is now closed

Senior Regulatory Affairs Associate - Glasgow

Engineering & Manufacturing - Engineering & Manufacturing
Ref: 5330 Date Posted: Thursday 10 May 2018
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Nine Twenty Engineering are assisting in the recruitment of a Senior Regulatory Affairs Associate for our West Central Scotland based Client. 

The Role:

Our clients Regulatory Affairs team ensure that our products and procedures are compliant with industry and governmental standards worldwide. 

The Regulatory Affairs team require an enthusiastic and conscientious individual to assist with the Regulatory workload associated with our clients medical device portfolio. 

Key responsibilities and duties will include

  • Perform Regulatory tasks as instructed.
  • Perform Regulatory tasks as required to ensure regulatory compliance.
  • Work towards meeting quality objectives as stated in quality system as applicable.

Position in Organisation 

  • Senior Member of the RA Department.
  • Reports to Regulatory Affairs Manager.
  • Frequent liaison at all levels throughout the company.
  • Externally liaises with Customers and Distributors.
  • Deputises for RA Associates.

Key Duties 

  • 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 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.

Company Requirements 

  • Ensure compliance with all current and future regulatory requirements.
  • Must work within requirements of company handbook and policy statements.

Quality Requirements 

  • Work within the quality system at all times.
  • Ensure accurate completion of quality records.
  • Highlight to immediate supervisor any areas which are not functioning correctly within the quality system.
  • Has responsibility to notify line manager if they become aware of an issue relating to regulatory / registrations.
  • Responsible to escalate issues relating to General H&S, product or process quality and compliance.
  • Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times.

Qualifications & Experience 

  • BSc Hons Degree.
  • Regulatory experience within a medical device or pharmaceutical environment is essential.
  • Able to communicate with personnel in QA/R&D and other departments.
  • Able to communicate with external parties:
  • Regulatory Authorities, Customers, Distributors, Notified Bodies, Competent Authorities.

If you feel like this role is for you, please get in touch with Caroline Strachan on 0141 231 1260.