Regulatory Specialist

  • Location
    Blackburn, Lancashire
  • Salary
    £ 40000 - £ 50000 / Year
  • Job type
    Permanent
  • Industry
    Engineering
  • External Reference
    120194
  • Category
    Engineering, Aerospace, Automotive - Engineering, Aerospace, Automotive

Adecco LifeSciences are proud to be partnering with a global manufacturing leader within the Medical Devices industry.

Reporting to the Director of Global Quality and Regulatory you will help build and sustain Quality Regulatory systems and processes and work closely on the collation of technical files for MDR compliance and global product submissions.

Requirements for this position include:

Review and administration of all aspects of Regulatory Affairs.
Maintenance and collations of technical files and drug master files, providing updates where required for product approvals, CE declarations and MDR compliance.
Experience of global product submissions (FDA advantageous but not essential)
Completion of internal audits to ISO 13485.
Knowledge of MDR and related legislation including ISO 13485, ISO 15378.
Regulatory management of customer complaints.

The company are looking to hire someone who is keen to continue their personal development as a Regulatory Specialist, with an aim for this role to become a senior or leadership position within a two-year period.

Looking for someone to start ASAP, if you are interested please get in touch.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder