Regulatory Specialist

  • Location
    Sheffield, South Yorkshire
  • Salary
    £ 35000 - £ 42000 / Year
  • Job type
  • Industry
    Manufacturing and Production
  • External Reference
  • Category
    Engineering, Aerospace, Automotive - Manufacturing & Production Engineering

Adecco Lifesciences are working with a long-standing and highly successful Medical Device manufacturer who is looking for a Regulatory Specialist to join the team on a permanent basis.

The existing team is already strong and so you will work alongside motivated and experienced RA Specialists supporting the company with Technical File remediation for existing products to ensure compliance to MDR (2017/745) and assist in the creation of technical documentation for new products being introduced in the New Year.

Day to day you can expect to:

Create and maintain Technical Files in accordance with EC Regulation 93/42/EEC.

Transition Technical Files from Medical Devices Directive (93/42/EEC) to Medical Devices Regulation (2017/745)

Compile Technical Files and documentation for review by the Notified Body.

Provide regulatory support for all post-market surveillance activities.

Maintain and approve product labeling to meet regulatory & UDI requirements.

Review marketing, promotional material, and website content for regulatory compliance.

Manage and maintain global distributors including UK, Europe, Australia, Canada, and USA.

Sound like it might be of interest?

If you are adaptable, productive and can work well in a team, you will thrive in this position.

As you will be working with high-risk devices, experience with Class iii or Orthopeadic devices is essential to understand the complexity of the technical file you are working with.

The business strives to offer each candidate continuous professional development and education allowing you to gain further knowledge in the regulatory field and this role is no different allowing you to build on your problem solving, regulatory strategy, life cycle management and technical file skills.

If this role is of interest and you have the relevant experience, then please apply and I will be in touch to talk in more detail.

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

To speak to a recruitment expert please contact Amy Holder