Compliance Officer, Engineering

Responsibilities

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.

Qualifications

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: IEC
60601-1 series, including collateral and X-ray specific standards.

Preffered: IEC
62304 and IEC
62366-1.

Preffered: EU MDR and 21

CFR
820.

Preffered:
Standards and regulations related to artificial intelligence.

Benefits

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.

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