- 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 Manager
- To provide technical support to the network on Regulations and Certification procedures
- To contribute in the day-to-day management of the Medical Devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance
- To provide expert regulatory and technical support at all stages of the medical device conformity assessment process to the network;
- To undertake PWS approval and audit team allocation activities related to medical device conformity assessment process for the network in accordance to company procedures
- To undertake reviews of audit packs and certification decisions of medical device conformity assessment packs in close collaboration with Operations in accordance to company procedures, KPI’s and targets.
- To plan and conduct professional medical device QMS audits in accordance with company procedures and approved technical areas to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards;
- To plan and undertake technical documentation assessments of medical devices in accordance with company procedures and approved technical areas to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards;
- To support the achievement of medical devices operational and financial targets;
- Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems, standards and compliance/auditing techniques (Essential)
- Minimum of 5 years working experience for a Medical Device Notified Body (Essential)
- Minimum of 5 years working experience as Medical Devices Lead Auditor and Product Assessor status (Essential)
- Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
- Willingness to learn and adapt to change – committed to continuous personal and professional development (Essential)
- 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)