Senior Regulatory Compliance Specialist IGT Systems

1 maand geleden


Tilburg, Noord-Brabant, Nederland Yacht Voltijd

Philips, a global leader in health technology, is committed to enhancing patient outcomes and advancing healthcare systems through meaningful innovation.

Job Summary

We are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team in Eindhoven. As a key member of our Norm Compliance team, you will be responsible for ensuring that our IGT systems comply with all applicable national and international laws, including Philips Healthcare procedures and MDR.

About the Role

This is an exciting opportunity to work on advanced health technology and solutions that enhance the lives of billions of people worldwide. You will have the chance to contribute to initiatives that will change lives and work collaboratively with cross-functional development teams.

Responsibilities
  • Identify relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products.
  • Develop and implement compliance plans while serving as a representative of the Norm Compliance team.
  • Create deliverables for norm compliance and ensure the implementation and verification of legal requirements.
  • Assist testers and designers in interpreting and evaluating rules and guidelines pertaining to the technical design of IGT products.
  • Assemble and finish documentation required for independent certifying bodies to certify products.
Requirements
  • Preferred knowledge in medical domain standards, including IEC 60601-1 series, IEC 62304, IEC 62366-1, EU MDR, and 21 CFR 820.
  • A strong understanding of regulatory compliance principles and practices.
  • Excellent communication and interpersonal skills.
What We Offer
  • A competitive salary based on industry standards (€80,000 - €110,000 per year).
  • An attractive benefits package, including pension scheme, home workplace allowance, quarterly bonus, and referral bonuses.
  • The opportunity to work on cutting-edge health technology and solutions that make a positive impact on global health and well-being.


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