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Regulatory Affairs Specialist

Regulatory Affairs Specialist

  • Location

    Hertfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    21909_1603732108

  • Published:

    about 1 month ago

  • Expiry date:

    2020-11-25

  • Consultant:

    #

Job title: Regulatory Affairs Specialist (Medical Devices) - UK/IE

A Pharmaceutical business in Hertfordshire are seeking an individual with extensive Medical devices experience to join their Regulatory Affairs Team as a Regulatory Affairs Specialist. In this role you will be responsible for maintaining marketing authorisations, assists in new MAAs and provide life cycle maintenance for various products.

Responsibilities:

  • Life Cycle Maintenance for existing products within the UK and Ireland (National, MRP and DCP)
  • Support Module 1 documents for new MAAs for both the UK and Ireland markets
  • Prepare, submit and manage applications with the MHRA and HPRA
  • Undertake 'ad-hoc' duties such as pharmacovigilance, labelling, artwork etc…
  • Maintain collaboration with EMEA counterparts

Requirements:

  • Minimum of 2 years' experience within Regulatory Affairs
  • Ideally a background in Medical Devices
  • Degree level educated within life sciences
  • Experience working within UK/IE markets (MHRA and HPRA)
  • Experience across National, MRP and DCP

Salary and benefits:

A competitive salary, annual bonus and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via freddie.hill@pharma-partners.co.uk