Regulatory Specialist

  • Category
    Engineering - Technical Author
  • Location
    Manchester, Manchester
  • Salary
    £35,000.00/Year
  • External Reference
    010921
  • OrganizationType
    IT

Adecco LifeSciences are looking for a Regulatory Specialist to join an IVD business and work within a small team to help deliver on the company's regulatory affairs strategy, understanding IVD frameworks and working on regional product submissions.
To be considered for this position we are looking for experience in the following:

-Maintenance of Technical Documentation in accordance with MDD, MDR, IVD or IVDR for CE marking.

-Support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.

-Complete product risk management activities and the life cycle of marketed products.

-Support post market surveillance, preparing reports for the product range.

-Knowledge of ISO 13485 and IVD/IVDR or MDD/MDR regulatory affairs requirements.

This is a unique opportunity to join an IVD business as they experience a growth phase and drive new products to market.
IVD experience is not essential but Medical Device knowledge a minimum of 6 months working within a Regulatory position is.
Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.

By applying for this role your details will be submitted to Spring. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.

To speak to a recruitment expert please contact Amy Holder