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Technical File Reviewer

Technical File Reviewer

Posted 18 November 2020 by SGS UK Limited
Ended

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

At SGS, we have an open corporate and international culture, we offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company.

Job Description

  • Job Title: Technical File Reviewer
  • Job Type: Permanent
  • Hours: 37.5 hours per week
  • Job Location: Multiple Locations, London | Birmingham | Manchester
  • Remuneration: As a Technical File Reviewer, you’ll receive a salary of between £50,000 and £70,000 per annum, depending on experience level, plus you’ll benefit from a 10% performance bonus private health cover, a contributory pension scheme and life cover.

As a Technical File Reviewer you’ll be responsible for conducting technical file reviews of Class 11a/11b (and Class III) and approve or raise queries based on technical and procedural knowledge. You’ll ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectations.

As a member of the Global Medical Device office (MDO) minimise risks associated with medical device certification.

Key Accountabilities;

  • Ensuring regulatory compliance of technical file reviews under applicable EU Medical Devices Directives and /or Regulations
  • Conducting reviews (primarily desk based, but occasionally may be on site) in accordance with established procedures, maintaining a high standard of service delivery.
  • Project manage reviews as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards
  • Work at all times to adhere to KPI’s set as an individual and within a team
  • Maintenance of MDD/MDR or IVD/IVR Product Assessor status
  • Ensure that the highest level of service is provided throughout the SGS network offering Medical Devices certification and final customers through efficient service delivery

Qualifications

To be successful in this role, you’ll need a degree or equivalent qualification in relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences

In addition to the above you’ll also need to demonstrate the following;

  • Professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
  • Medical device knowledge/codes
  • Technical File reviews
  • Good communication techniques through electronic mediums

The following attributes would be desirable, but not essential;

  • Lead Auditor Qualification
  • Broad range of codes and previous Technical File review experience
  • Experience of working to KPI’s

Additional Information

APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days

Reference: 41398992

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