Position : Medical Device - Lead Auditor
Type : Permanent
Role Overview
A Notified Body in the Netherlands are rapidly expanding their Audit teams as a result of a large project acquisition. This Notified Body has numerous subsidiaries across Europe and offers world renowned, fully funded training programs to attain all of the necessary Certificates.
Key Responsibilities
- Conduct customer audits in accordance with EU requirements and designations
- Creation of customer evaluation forms / audit reports
- Customer interaction and business development responsibilities
- Continuously up to date with current MDD / MDR 2017 / 745 or IVDR 2017 / 746 requirements
- Conformity assessment of MDR / IVDR of medical devices
- Customer complaint management
Essential Criteria
Successfully completed Scientific or Engineering degree (BSc / Msc)4+ years’ experience within Medical Device Industry (existing Notified Body experience preferred)2+ years’ within Research & Development, Quality, Regulatory for Active and / or Non-ActiveKnowledge of working under and / or implementing systems related to MDR (2017 / 745)Internal / External Audit experience (preferred)Fluent in English and professional knowledge of DutchExcellent verbal and communication skillsBenefits
Work for a Leading Notified BodyExcellent fully funded training programsRegular salary reviews once onboarded