Device Technical Regulatory Associate Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €50,000 - €80,000
Medical Device Regulatory Expert

We are seeking a highly skilled Medical Device Regulatory Expert to support the planning, implementation, and execution of medical device portfolio management.

Key Responsibilities
  • Gather and disseminate regulatory intelligence including guidance, policy, standards, and laws governing medical devices.
  • Ensure compliance with European Medical Device Regulation (EU) 2017/745 for Drug-Device Combination Products.
  • Support global objectives for European regulatory agency engagements and submission activities.

The successful candidate will work closely with our global teams to design, develop, and commercialize Drug-Device Combination Products. A strong understanding of quality systems and regulatory compliance is essential for this role.

Responsibilities include:

  • Portfolio Management: Collaborate with cross-functional teams to plan, implement, and execute medical device portfolio management strategies.
  • Regulatory Intelligence: Gather and disseminate regulatory intelligence, including guidance, policy, standards, and laws governing medical devices.
  • Compliance: Ensure compliance with European Medical Device Regulation (EU) 2017/745 for Drug-Device Combination Products.
  • Global Objectives: Support global objectives for European regulatory agency engagements and submission activities.

This role requires a high level of expertise in medical device regulation and a proven track record of ensuring regulatory compliance. If you have a strong understanding of quality systems and regulatory requirements, we encourage you to apply.

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