Jul 16, 2021

Quality and Regulatory Affairs Manager

  • Metix Ltd
  • Glasgow, UK
Full time Quality Regulatory

Job Description

Metix is an established and successful medical technology company that is currently developing the next generation of medical devices that have the potential to improve medical care in pre-hospital care settings. We are looking for a Quality and Regulatory Affairs Manager who is versatile, enthusiastic and displays leadership qualities.

Areas of work include but are not limited to:

  • Develop, monitor, improve, and maintain documentation to ensure compliance with ISO13485 and CFR 820.
  • Provides guidance and support in Quality related matters across different departments.
  • Liaise with supplier evaluation, selection, and approval.
  • Conduct internal, external, supplier audits and inspections.
  • Liaise with the notified bodies and applicable regulatory authorities.
  • Deal with NCRs, CAPA, Change Control.
  • Identifies regulatory applicable requirements to Metix products.
  • Preparation of regulatory submissions for Europe, the US, and other markets.
  • Keeping up to date with national and international applicable regulations.
  • Liaising with the internal team members to provide the relevant information to support the regulatory process and ensure compliance.
  • Evaluating current technical documentation for compliance with the applicable regulations (such as MDR and CFR 820), including validation requirements required for regulatory approval
  • Coordinates the Quality and Regulatory Affairs team.

Qualifications and Skills

Essential Requirements:

BSc in Biomedical Engineering, Electrical engineering or another relevant scientific discipline including Life Sciences/biomedical science.

  • Capable of working independently and proactively.
  • Good general IT skills and the ability to work with spreadsheets, word packages, PowerPoint, etc.;
  • Attention to detail
  • Effective communicator
  • Good analytical skills and critical thinking

Desirable Qualifications & Experience:

Awareness of both quality and regulatory affairs and understanding of both legal and scientific matters.

  • Knowledge or experience in ISO 13485:2016 and CFR 820.
  • Prior Knowledge of MDR, FDA, or other regulations.

Working with Metix Ltd you can expect a professional and dynamic environment with teamwork at the core of it. We tend to look for who is:

BENEFITS

This position in a multi-award-winning Medtech company is challenging and rewarding at the same time. You will be working in a flexible multi-cultural environment, under the direct supervision of the CEO and COO. You may interact with technical teams internationally either remotely or in person. The current company structure allows for fast professional growth for exceptional performers.

Additional Benefits:

  • Flexible working hours
  • Relaxed working environment
  • Short walking distance from Glasgow Central Station
  • Casual dress code
  • 35-hour contract with an hour lunch

For further information on Metix, please visit our site: www.metixmedical.co.uk or follow us on Twitter: https://twitter.com/MetixMedical/

The successful candidate must have permission to work in the UK by the start of their employment


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