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Regulatory Engineer

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Elastic Ltd

2024-09-21 03:33:37

Job location Lancaster, Lancashire, United Kingdom

Job type: fulltime

Job industry: Engineering

Job description

Regulatory Engineer - Medical Devices - Competitive Salary and Benefits

A rapidly expanding company in Lancaster is seeking a Regulatory Engineer with experience in the Medical Device sector to join their dynamic team.

You will be instrumental in ensuring regulatory compliance across the company's portfolio, helping to bring innovative healthcare solutions to market.

As a Regulatory Engineer, you will compile and update technical documentation, support regulatory submissions, participate in audits with internal and external stakeholders, ensure ongoing compliance with ISO standards, and investigate non-conformities.

Essential experience:

  • Knowledge of medical device regulations (e.g., ISO 13485)
  • Experience with product registrations in global markets
  • Regulatory documentation and technical file management
  • Prior experience in conducting audits to quality standards
Desirable experience:
  • Hands-on experience in quality management systems (QMS)
  • Knowledge of medical air filtration and PPE products
  • Prior experience implementing and upholding health and safety standards
If you re interested in the Regulatory Engineer opportunity and would like further information or are interested in making an application, please contact Luke Ord.

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