EC Design Examination Assessor - £60,000-£65,000

Weston-Super-Mare  ‐ Onsite
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Description

Due to changing regulations and a planned growth this huge UK Notified Body is now recruiting for a EC Design Examiner for their Soft tissue (resorbable) & Vascular divisions.

The main responsibilities of this position are;
  • To plan and conduct professional ECDE reviews in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate Competent Authority expectations and standards
  • To assist in business development as required and to provide specific technical support both in the area of technical specialist (e.g. cardiovascular or orthopaedic etc) and horizontal skills (e.g. clinical evaluation, risk management) to expand the Company's capability to offer valued services to customers
  • Ensure the highest level of service is provided to global customers through efficient service delivery and adherence to SGS procedures and processes and to promote SGS as the preferred supplier of EC Design Examinations
  • To undertake peer review and calibration of design dossier reviews to ensure reviews meet current best practice
  • To undertake technical documentation assessments of non class III medical devices
    To plan and deliver internal training and mentoring to auditors performing technical file reviews
  • Conduct ECDE reviews (primarily desk-based, but occasionally may be on client's sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships
  • Conduct reviews of technical documentation of non class III medical devices
  • Facilitate the acquisition of new ECDE clients by providing technical support and guidance to global sale and marketing teams
  • Deliver internal training in specialist technical area and generic skills to auditors performing technical file reviews
  • Provide technical support and staff training to all parts of the business covering horizontal expertise areas to enhance the service capability of the business


Essential requirements;
  • First degree, or equivalent in relevant life science - i.e. BA/BSc, HND, Chartered Engineer etc.
  • Minimum 4 years practical experience in the medical sector
    Minimum 3 years experience undertaking Class III conformity assessment reviews within a well respected notified body
    Demonstrable track record of reviewing high risk devices in the chosen area of specialism (e.g. cardiovascular or soft tissue (resorbable) implants etc)
  • Must be able to demonstrate both an excellent technical expertise in specialist area (i.e. cardiovascular or soft tissue (resorbable) implants etc) and working knowledge of medical device regulatory systems, standards and compliance/auditing techniques
    Must have a detailed understanding of the relevant medical device regulations and international/harmonised standards for which audits/technical reviews are being undertaken
  • Effective interpersonal skills; able to develop good working relationships with people at all levels
  • Able to communicate clinical and technical issues to all stakeholders
  • Able to demonstrate attention to detail
  • Ability to read/speak a foreign language


My client is looking to pay from £60,000-£65,000 + very generous benefits for the correct candidate.

If you believe you have the correct experience then please send me your CV and I will be in touch shortly.
Start date
03/2015
From
Real Staffing
Published at
28.02.2015
Project ID:
859792
Contract type
Permanent
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