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Regulatory Affairs Specialist

The Binding Site
Job LocationBirmingham
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

DescriptionRegulatory AffairsSpecialistWould you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovationDo you want to make a differenceIfthe answer is yes’ then you’re just the kind of person we’re looking for!We are looking for a Regulatory Affairs Specialist who is organised, committed, methodical, passionate individual to work in our busy Regulatory affairs department.Alongside team management, the Regulatory Affairs Specialist is responsible for assisting in all global regulatory affairs activities to contribute to overall company objectives.This role is REMOTE and can be based anywhere within the UK with Head office based in Birmingham.The Roleincludes: -

  • To assist in regulatory affairs projects for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM
  • Support key development projects to meet strategic business objectives
  • Assist in global submissions including EU, FDA
  • Support Internal audits
  • Regulatory review all controlled documents
  • Support internal audits
  • Support 3rd party audits
  • Support compliance activities for QMS to meet regulatory requirements including MDSAP
    • Experiencerequired: -
  • A relevant scientific degree B.Sc. in Life sciences or M.Sc. or higher in life sciences or equivalent.
  • Several years in QA/RA roles in healthcare industry (pharma, medical devices, or diagnostics
  • IVD industry experience
  • Global registration
  • R&D clinical, production research & development
    • Working for us:Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.Location: Head Office BirminghamHours: 40 hrs (5 days remote working)Benefits:
  • Competitive Salary
  • Contributory Pension
  • 25 days paid holiday plus bank holidays
    • Required skills
  • Clinical
  • R&D
  • ivd
  • live sciences

    • Keyskills :
    live sciences

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