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Medical Device Technical Pack Reviewer / Certification Decision Maker - Belgium  

Company managed [?] Still accepting applications

Posted on : 11 April 2017

Project Description

Description:
  • Our company  is the global leader and innovator in inspection, verification, testing and certification services. 
  • Founded in 1878,our company  is recognized as the global benchmark in quality and integrity. 
  • Trusted all over the world, our company  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. 



Medical Device Technical Pack Reviewer / Certification Decision Maker 
Job description: 
  • To undertake technical reviews and certification decisions of audit packs within target timescales and in line with company policies and accreditation/approval requirements 
  • Provide accurate and timely reporting as required by line management to assist the planning and management of operations 
  • Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge 
  • To maintain a full knowledge and understanding of company procedures and external approval criteria to allow efficient and effective technical reviews. 
  • To undertake other technical tasks as requested and support affiliates on technical projects 
  • Maintain medical device auditor status whilst not undertaking significant number of audits 




Profile: 
  •  Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems [MDD, IVDD, Accreditation], standards and compliance/auditing techniques (Essential) 
  •  Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential) 
  •  Must be IT literate i.e. competent in the use of MS Office applications (Essential) 
  •  Willingness to learn and adapt to change – committed to continuous personal and professional development (Essential) 
  •  Minimum of 2 years working for a Medical Device Notified Body 
  •  Minimum of 5 years medical device experience from auditing/work ( Essential) 
  •  Minimum 3 year experience auditing against recognised standards (Essential) 
  •  Approval as a Notified Body Product Assessor (not required to be active but must have had in past with NB) 
  •  MDD, IVDD, CMDCAS auditor approval or part off (not required to be active but must have had in past with NB) 
  •  Experience of working under own initiative and in planning and prioritising workloads (Essential) 
  •  Experience of reviewing audit packs (Desirable) 
  •  Registered IRCA lead auditor, or equivalent registration under other recognised body (Desirable) 
  •  University Degree or equivalent