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Medical Device Certification Manager - Belgium  

Company managed [?] Still accepting applications
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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 Certification Manager 

Job description: 
  • Ensure the integrity and compliance of all medical device certification processes and decisions 
  • Liaise with third party stakeholders (Regulatory Authorities) to ensure that certified organizations and devices comply with the standards and regulations and that patient safety is maintained 
  •  Maintain required approvals and accreditation and manage the business risks to our company.
  •  Ensure the highest level of service through efficient service delivery / process optimization. 
  •  Manage all critical conformity assessment processes (contract approval, assessment staff approval, assessment pack review and certification decision) provide to network 
  •  Ensure that all assessment personnel follow current procedures and that all certification decisions are correctly based on documented assessment evidence. 
  •  Ensure that appropriate impartiality and confidentiality are maintained by all medical device staff 
  •  Develop and approve appropriate training of medical device staff and ensure that all conformity assessment staff are suitably qualified and trained 
  •  To support the achievement of medical devices operational and financial targets; 



Profile: 
  •  Extensive knowledge and experience of the medical device certification business and regulations. 
  •  A minimum of 5 years quality assurance and assessment experience including working for a Medical Device certification body 
  •  University degree in a directly relevant technical subject further qualification desirable 
  •  Clinical or direct device experience desirable 
  •  Fluent in English , multiple language proficiency an advantage 
  •  Team management experience 
  •  Ability to work with management, technical auditing and administrative personnel at a corporate , international and affiliate level 
  •  Ability to understand customer and market expectations and to be customer focused at a global and affiliate level. 
  •  Excellent interpersonal and communication skills ( highly developed presentation skills )
  •  Negotiation and persuasion skills 
  •  Change and Conflict Management skills 
  •  Strong organizational skills and flexibility