Bedrijfsomschrijving
Philips is a global leader in health technology, committed to improving people's lives through meaningful innovation. With a strong focus on enhancing patient outcomes and advancing healthcare systems, Philips provides a wide range of solutions spanning medical devices, diagnostics, and digital health. The company is dedicated to delivering high-quality, sustainable products that drive improvements in both clinical and personal healthcare environments. By combining cutting-edge technology with a deep understanding of customer needs, Philips continues to make a positive impact on global health and well-being.
Functieomschrijving
Regulatory Compliance Officer - IGT Systems
(We are looking for candidates who are currently based in the Netherlands)
Start Date:ASAP
Duration of the contract: 1 year
Location:Eindhoven
Support the Norm Compliance team's efforts and deliverables for IGT-systems that adhere to all applicable national and international laws, including Philips Healthcare procedures and MDR.
Develop and implement the standards and compliance plan while serving as a representative of the Norm Compliance team in a cross-functional development team.
Working at Philips will allow you to contribute to advanced health technology and solutions that enhance the lives of billions of people worldwide and work on initiatives that will change lives.
Functie-eisen
- Identifying relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products.
- Defining the plan to incorporate rules and guidelines for demonstrating compliance
- Creating deliverables for norm compliance and ensuring the implementation and verification of legal requirements.
-Assisting testers and designers in interpreting and evaluating rules and guidelines pertaining to the technical design of IGT products
-Assembling and finishing the documentation required for the independent certifying body to certify the product
-Providing technical support to the Regulatory Affairs division for preparing submissions to regulatory bodies and authorities.
Preferred knowledge in the following medical domain standards:
Arbeidsvoorwaarden
Primary Employment Conditions:
Secondary Employment Conditions:
werkzoekende
Recruiter