Medical Device Regulatory Affairs Expert

hace 22 horas


Alajuela, Alajuela, Costa Rica Philips A tiempo completo
Job Overview

Philips, a global leader in health technology, is seeking an experienced Medical Device Regulatory Affairs Expert to join their team. This role plays a crucial part in ensuring compliance with regulatory requirements and standards for medical devices.

The ideal candidate will have a strong background in design controls, medical device regulations (21CFR, ISO 13485), and FDA Law. They will be responsible for managing the lifecycle of medical devices, from development to commercialization, while ensuring adherence to regulatory guidelines.

Key Responsibilities
  • Evaluate changes to standards and regulations affecting Philips' products and maintain a process to inform relevant teams about potential impacts.
  • Manage projects related to ensuring compliance with medical device standards and guidance within Philips' Quality Management System (QMS).
  • Train Costa Rica site personnel on Regulatory Affairs responsibilities and foster collaboration across departments.
  • Support audits by providing active support and collaboration to audit teams.
Requirements
  • Bachelor's degree in a technical discipline or equivalent experience in a related field.
  • Minimum 3-5 years of experience in the medical device or pharmaceutical industry and technical environment.
  • Strong background in design controls and medical device regulations.
  • Excellent working knowledge of medical device regulations, FDA Law, and MDR.
  • Experience in supporting international registrations.
  • Advanced English language skills.
What We Offer

In return for your expertise, we offer a competitive salary of $120,000 - $150,000 per year, depending on location and experience. As a Medical Device Regulatory Affairs Expert at Philips, you will have the opportunity to work on innovative health technology solutions that improve lives worldwide.

We value flexibility, encouragement, and opportunities for growth. Join us in creating meaningful solutions that make a real difference in people's lives.



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