Compliance Officer
Trinamics
- 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.
- 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.
- 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.
