Functieomschrijving

• Defining applicable standards and regulations for new products, such as IEC 60601 series, IEC 62304, IEC 62366-1, and EU MDR.
• Outlining how these standards and regulations will be integrated into the Standards and Compliance plan to demonstrate compliance.
• Creating project deliverables related to Norm Compliance.
• Ensuring all specified legal requirements are implemented and verified by reviewing relevant project deliverables.
• Assisting designers and testers with the interpretation and application of standards and regulations related to the technical design of IGT products.
• Organizing and completing all documentation required to obtain product certification from independent certifying agencies.
• Providing technical support to the Regulatory Affairs department in preparation for submissions to regulatory bodies.

Functie-eisen

• A bachelor’s degree or higher in a technical field, health sciences, or a related discipline.
• At least 3-5 years of experience in software and/or hardware testing/engineering or similar roles in a complex environment.
• A background in the global medical devices industry is a strong advantage.
• Knowledge of product safety standards, such as IEC 60601, is preferred.
• Familiarity with other national and international regulations is a plus.
• Preffered: IEC60601-1 series, including collateral and X-ray specific standards.
• Preffered: IEC62304 and IEC62366-1.
• Preffered: EU MDR and 21CFR820.
• Preffered: Standards and regulations related to artificial intelligence.

Arbeidsvoorwaarden

• The right candidate will be provided a challenging and varied position in a professional, high-tech environment.
• An appropriate salary based on your experience and education.
• Future prospects and excellent benefits are evident.
• After a period of secondment and functioning properly, you can be contracted by our client.
• Good secondary conditions such as a minimum of 25 holidays and 8,33% holiday allowance.
• Courses to develop yourself professionally and personally via Trinamics Academy.
• Discount on your healthcare and referral bonusses and fun activities.
• Certain pre-employment screening checks may be part of this vacancy procedure.