Medical Device Technical Pack Reviewer / Certification Decision Maker - Belgium
- 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
- 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
- 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