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Department Leader, Regulatory Affairs

Posted Date: 12-Oct-2021

Location: Penicuik, GB, EH26 0BF

Company: Quotient

We are recruiting for a Department Leader, Regulatory Affairs to join the Regulatory Affairs team based near Penicuik, Midlothian (EH26 0BF). The role is a full time (37.5 hours per week), permanent position with flexible working options.


The role is responsible for: ensuring the continued registration for all Quotient products after initial registration or approval, managing and supporting regulatory affairs officers and team members; acting as an active participant in team meetings that relate to changes to developed products that will require further registration and regulatory submissions and; supporting customer organisations.

 

JOB DESCRIPTION
The main responsibilities will include:

  • Serve as a member of the Regulatory and Quality Management Team
  • Manage, prepare and maintain regulatory documentation
  • Lead in the management, planning, co-ordination, preparation and interpretation of relevant information necessary for product licence applications

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • relevant degree or professional qualification and extensive experience in a regulatory affairs environment.
  • Regulatory Affairs Professional Society certification or advanced degree in regulatory affairs
  • Appropriate experience in filing BLA, 510(k) and PMA submissions, CE marks and experience in manufacturing environment

 

ADDITIONAL INFORMATION

  • Competitive salary on offer
  • Quotient offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.