Job Overview
The Medical Devices department is a notified body for various schemes, including the Medical Devices Directive 93/42/EEC and the Medical Devices Regulation 2017/745.
We are accredited to assessment services like MDSAP Recognised Auditing Organization and ISO 13485 Certification Body Auditing.
Key Tasks and Responsibilities:
* Act as primary point of contact for new business enquiries worldwide.
* Process new business enquiries through customer relations management software.
* Perform contract review according to ISO 17021 and MDR 2017/745.
* Provide quotation service for new business enquiries.
* Liaise with client service representatives and medical device operations managers for scheduling audits and product reviews.
* Represent NSAI at national and international conferences.
* Support the transition of existing clients from MDD/IVDD to MDR/IVDR.
Qualifications and Experience:
Suitable candidates should hold a university degree or equivalent in science, engineering, or healthcare-related studies.
A minimum of four years of professional experience in healthcare products or related activities is required, with two years in design, manufacture, testing, or use of devices or technologies to be assessed.