Job Description

A successful and continually expanding Medical Device manufacturer are seeking a Quality Assurance and Regulatory Affairs Manager to join them at their site in Kent. This well-established company supply the leading brands of a variety of products and materials both within the UK and internationally.

Role Overview

• Oversee, organise, plan, and direct the Regulatory Affairs and Quality Management function within the business.

• Develop Procedures and Policies to ensure adherence to the company’s Quality System and Regulatory Standards.
• Ensure all relevant quality and regulatory standards are adhered to, including ISO13485, FDA and GMP.
• Liaise with Notified Bodies and relevant authorities as required.
• Manage, Maintain and Optimise the company’s Quality Management System (QMS) in accordance with ISO9001 and ISO13485.
• Manage the Regulatory Team.

To be considered...

Requirements

• Degree or Equivalent in relevant Scientific or Engineering Discipline
• In-depth knowledge of the regulatory requirements of taking Class I & II Medical Devices to Market within Europe and ideally experience with international Markets.
• Strong working knowledge of MDD/MDR
• Experience of QMS Management
• Strong leadership, communication, and organisational skills.

In return:

You will benefit from a competitive salary and benefits package and benefit from working amongst a supportive and motivational team, with opportunities for progression as the company continues to expand.

If you feel this role is not right for you but are interested in other medical device jobs have a look at our jobs page.

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