Regulatory and Quality Specialist

Manpower UK is recruiting on behalf of our Liverpool based client for a Regulatory and Quality Specialist to join a small but successful team.

Our client is a start-up medical device company focused on the development of cutting-edge technologies that enhance the safety of enteral access.

As the Regulatory and Quality Specialist you will be responsible for the following:-

Regulatory

To support the Regulatory affairs and Quality Assurance Manager in ensuring the company complies with regulatory requirements, industry standards and customer requirements.

• Maintain the company technical files in accordance with the MDD, MDR and FDA regulations and internal requirements.
• Establish and maintain company registrations with appropriate regulatory bodies in the marketplaces our clients products are sold in.
• Conduct Post Market surveillance activities

Quality

Conduct Manufacturing and Quality control tasks whilst supporting product development and commercialisation.

• Conduct Quality Assurance tasks to maintain patient safety, device efficiency and cost effective delivery of the company products to market.
• Assist in the maintenance, development and implementation of the ISO 13485 Quality Management (QMS).
• Working within QMS to carry out company operations such as post market surveillance, change control, customer services, research, product development, testing and product support.

Other duties:-

• Supporting day to day operations
• Regulatory affairs and Quality Assurance Manager and CEO
• Additional training and field support.

We are looking for a candidate with a minimum of 5 years in a Medical Devices or Pharmaceutical company and has experience of Class 1/2 A and ISO 13485 and ideally have a degree in a Scientific based discipline, but this is not essential.

If you are looking for a new opportunity with a great company, please forward your CV in the first instance.