Regulatory Compliance Engineer

3 weeks ago


Oxford, Oxfordshire, United Kingdom Newton Colmore Consulting Ltd Full time

Position: Quality Assurance Engineer

We are seeking a dedicated Quality Assurance Engineer to join our innovative medical device start-up. This organization is at the forefront of developing groundbreaking medical technologies that significantly enhance patient outcomes.

In this role, you will work closely with the Quality Assurance Manager and collaborate with a diverse team of experts, including Mechanical Engineers, Physicists, Electronics Engineers, and Software Engineers. Your primary responsibility will be to ensure the quality of medical devices in compliance with ISO 13485 standards. Familiarity with 21 CFR Part 820 or regulatory affairs would be beneficial.

Key Responsibilities:

  • Implement and maintain the Quality Management System (QMS).
  • Conduct validation processes for medical devices.
  • Engage in risk management and internal auditing activities.
  • Support various quality assurance tasks as required.

The company is in the process of relocating, and initially, this position will be hybrid, requiring attendance at the current site a few days a week. Once the move is complete, the role will transition to a full-time on-site position.

We welcome candidates with a degree in a relevant field or those who have gained experience through alternative pathways in the medical devices sector. A background in biotechnology is also considered, provided you possess knowledge of ISO 13485 standards.

This role presents an exciting opportunity for professional growth and offers a competitive benefits package, including equity options, life insurance, pension contributions, private healthcare, income protection, and employee discounts.

We are open to candidates with varying levels of experience, provided they demonstrate the right attitude and commitment to quality. If you are interested in this opportunity, we encourage you to submit your application.

For further inquiries, please reach out to our recruitment team.


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