Senior Regulatory Compliance Expert for IGT Systems
1 week geleden
As a global leader in health technology, Philips is dedicated to improving people's lives through meaningful innovation. Our commitment to enhancing patient outcomes and advancing healthcare systems drives us to provide a wide range of solutions spanning medical devices, diagnostics, and digital health.
Job Description
The Regulatory Compliance Officer - IGT Systems will 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. This role requires developing and implementing standards and compliance plans while serving as a representative of the Norm Compliance team in cross-functional development teams.
Required Skills and Qualifications
To succeed in this role, you should have expertise in identifying relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products. You should also be able to define the plan to incorporate rules and guidelines for demonstrating compliance and create deliverables for norm compliance. Additionally, assisting testers and designers in interpreting and evaluating rules and guidelines pertaining to technical design is essential. Furthermore, assembling and finishing documentation required for independent certifying bodies to certify products and providing technical support to the Regulatory Affairs division are crucial aspects of this role. It is preferred to have knowledge in the following medical domain standards: IEC 60601-1 series, including collateral and X-ray-related standards; IEC 62304 and IEC 62366-1; EU MDR and 21 CFR 820; and AI-related standards and regulations.
Benefits
This position offers a competitive salary based on industry standards, considering degree and experience. The annual salary ranges from €65,000 to €85,000 depending on qualifications and performance. Additional benefits include a 13th month salary, 8.33% holiday pay, pension scheme, home workplace allowance, quarterly bonus, vacation days, travel expenses reimbursement, yacht academy training budget, and referral bonuses.
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