Compliance Specialist
7 dagen geleden
As a Compliance Officer at Yacht, you will be part of our Norm Compliance team, supporting the development and execution of standards and compliance plans for our IGT systems. Your expertise in international and national regulations, including MDR and Philips Healthcare processes, will be crucial in ensuring our products meet the required standards.
Your Responsibilities:- Define Applicable Standards: Identify the relevant standards and regulations for our products, such as IEC 60601 series, IEC 62304, and EU MDR.
- Develop Compliance Plans: Create project deliverables related to Norm Compliance responsibilities and ensure the implementation and verification of all specified legal requirements.
- Support Design and Testing: Collaborate with designers and testers to interpret and test standards and regulations, ensuring our products meet the required technical design.
- Certification and Regulatory Affairs: Arrange and complete evidence for gaining product certification by the independent certifying agency and provide technical support to the Regulatory Affairs department.
- A bachelor's degree or higher in a technical field, health sciences, or related.
- At least 3-5 years of experience in Software and/or hardware Testing/Engineering or similar roles within a complex environment.
- A background in the global medical devices industry is a strong plus.
- Knowledge of product safety standards, such as IEC, is preferred.
- Familiarity with other national and international regulations is an advantage.
- Well-developed project management skills are preferred.
- Proven experience in improvement activities and audits is an advantage.
- IEC series, including collateral- and X-ray related particular standards.
- IEC 62304 and IEC 62366-1.
- EU MDR and 21 CFR 820.
- Artificial intelligence-related standards and regulations.
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