Philips
Compliance Officer
Join the Norm Compliance team and contribute to ensuring IGT Systems meet mandatory international and national regulations, including MDR and Philips Healthcare processes. Work within a cross-functional development team to develop and execute standards and compliance plans.
Key Responsibilities:
Define applicable standards and regulations (e.g., IEC 60601 series, IEC 62304, IEC 62366-1, EU MDR) for product development.
Develop and execute a comprehensive Standards and Compliance plan to ensure evidence of compliance.
Create project deliverables related to Norm Compliance activities.
Verify and implement specified legal requirements by reviewing project deliverables.
Provide technical guidance to designers and testers for compliance with standards.
Arrange product certifications with independent certifying agencies.
Support the Regulatory Affairs department with technical inputs for submissions to regulatory bodies.
Skills and Qualifications Required:
Education: Bachelor’s degree or higher in a technical field, health sciences, or a related discipline.
Experience: 3-5 years in software/hardware testing, engineering, or similar roles in a complex environment.
Preferred Background:
Experience in the global medical devices industry.
Knowledge of product safety standards such as IEC 60601.
Familiarity with global regulations and standards (EU MDR, 21 CFR 820).
Project management expertise and experience in improvement activities and audits.
Preferred Standards Knowledge:
IEC Standards: 60601-1 series, including collateral and X-ray particular standards.
Medical Standards: IEC 62304 (software lifecycle), IEC 62366-1 (usability), EU MDR, 21 CFR 820.
Emerging Technologies: Artificial intelligence standards and regulations.
In return, we offer you:
For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise, and become an even more sought-after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.