E&O Laboratories Ltd., an employee ownership trust company, is a high growth microbiology culture media manufacturer, based in Central Scotland with two GMP facilities and a donor animal farm. We are seeking a Quality Assurance Assistant, specialising in Regulatory Affairs to join our busy and dynamic Quality team. This is an excellent opportunity for a person who enjoys working within quality management in a busy modern manufacturing environment.

This role involves assisting the Quality Manager with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.

  • Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, IVD and other regulatory requirements.
  • Act as Person responsible for regulatory compliance (PRRC) in accordance with article 15 of IVDR to ensure conformity of devices.
  • Maintain regulatory databases ensuring product information is maintained.
  • Take responsibility for promotion of regulatory awareness and awareness of customer requirements across the business.
  • Assist with regulatory, customer and third-party audits of the business.
  • Assist with the CAPA process ensuring actions are completed in line with business deadlines.
  • Ensure approved suppliers and external providers files are updated.
  • Assist with continuous improvement with regard to risk management and post market surveillance.
  • Assist with the QMS documentation requests both internal and external.
  • Prepare internal and external reports and collate data.

To be considered for the role, you must closely match the following criteria:

  • Bachelor’s Degree in a related field is required and minimum 1 years’ experience in medical devices or IVD regulation or regulatory activities or minimum 4 years’ experience in medical devices or IVD regulation or regulatory activities.
  • Knowledge of Quality Management systems, especially ISO 13485.
  • Experienced user of MS Office suite.
  • Strong written and oral communication skills

For more information, please see our website  www.eolabs.com

To apply please email your CV and your salary expectations.