Technical Compliance Engineer

3 weeks ago

City, United Kingdom Yolk Recruitment Full time

Technical Compliance Engineer

Up to 50,000

Cardiff

Yolk Recruitment has a new opportunity for a Technical Compliance Engineer to join an expanding manufacturer who are leading competitors within the Medical Sector.

This role reports directly to the Technical Manager and is within the Engineering function. It is an opportunity for an established Technical Compliance Engineer to join a secure company who offer professional growth and development.

What you will be doing as Technical Compliance Engineer:

  • Responsible for identification, monitoring, interpretation of global product compliance standards/regulations including IEC(phone number removed) Part 1 and Part 2 standards.
  • Facilitate and drive the change control process of standards and drive communication and knowledge exchange regarding impact assessment.
  • Responsible for contact with Test Laboratories and providing input to projects with certification strategy for testing in Test Laboratories.
  • 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
  • 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
  • Assist in preparation for and participate in regulatory agency audits.
  • Updates, reviews and assists in departmental procedures, policies as required
  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

The skills you will bring as Technical Compliance Engineer:

  • Experience of working with international medical device regulations and registration.
  • 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.
  • Must have the ability to understand and generate complex documentation.
  • Ability to coordinate, facilitate and work well in cross-functional teams.
  • Must be able to provide clear and accurate judgements.
  • Must be able to manage projects systematically

If you feel you have the skills, experience and passion to be successful in this Technical Compliance role apply now

Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.

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