Job Overview
The Medical Devices department is a notified body for various schemes, including the Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC, and In Vitro Diagnostic Medical Devices Directive 98/79/EC.
Key Tasks and Responsibilities
* Act as primary point of contact for all new business enquiries worldwide.
* Process new business enquiries through the customer relations management software.
* Perform contract review as per ISO 17021/MEDR 2017/745/IVDR 2017/745/MDSAP.
* Provide quotation service for new business enquiries.
* Liaise with client service representatives and medical device operations managers to aid in scheduling audits and product reviews.
* Represent NSAI at national and international conferences.
* Support the transition of existing clients from MDD/IVDD into MDR/IVDR through contracting, quotation, and scheduling activities.
Qualifications and Experience
A successful completion of a university or technical college degree in relevant studies, such as science, engineering, or healthcare-related studies, is required. Four years of professional experience in the field of healthcare products or related activities are necessary, including two years in the design, manufacture, testing, or use of devices or technology to be assessed.