Banner Default Image

Technical Compliance Engineer

Back to job search

Technical Compliance Engineer

  • Location:

    Cardiff

  • Sector:

    Construction & Industrial

  • Job type:

    Permanent

  • Salary:

    £40k – 50k

  • Contact:

    St David Recruitment Services

  • Contact email:

    info@stdavid-recruitment.co.uk

  • Contact phone:

    02920797920

  • Job ref:

    PEM1463

  • Published:

    22 days ago

  • Expiry date:

    2024-06-22

Technical Compliance Engineer
Cardiff
Permanent
Salary - £40k – 50k
Hours – Monday to Thursday 8:00am – 4:30pm, Friday 8:00am – 4:00pm
(Flexitime available)


Our Client within the Medical sector in Cardiff is looking for a Technical Compliance Engineer to join their team!


Essential
• Qualified to degree level in Engineering or science discipline.
• Minimum of 2 years’ experience working with international medical device regulations and standards.
• Expertise in the area of Technical standards and regulations (Product / technology / state of the art).
• Knowledge of coordination with test agencies and surveillance of certifications.
• Must be able to interpret information in standards and rationalize for use by Engineers.
• Conversant in Microsoft Word and Excel.
• Excellent written and verbal communication skills in English.

Role and Responsibilities
• Work as part of the Engineering team in relation to all products (NMI and Maintenance)
• Identify, monitor new and revised versions of Technical standards/regulations within scope.
• Maintain procedures for monitoring of Technical standards/regulations (LIS-007 and SOP-043)
• Perform GAP analyses and facilitate impact assessments and distribute into all projects.
• Communicate knowledge exchange regarding impact assessments, providing general guidance on how to interpret standards and regulations.
• Produce and support clear and concise rationales to support the Technical impact assessments.
• Drive the TrackWise process for new/revised standards and regulations including follow up on implementation of changes.
• Coordinate regulatory key processes requiring certified testing by a test house / Certified body.
• Supporting contact with test agencies
• Assists in preparation for and participate in regulatory agency audits.
• Updates, reviews and assists in departmental procedures, policies as required.

If this role is of interest, please contact us today!