Medical Device Certification Manager - Belgium
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- 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
- 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;
- 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