Senior Device Development Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000

Job Overview

Our organization is seeking a highly skilled and experienced Technical Regulatory Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements for device development programs.

As a Technical Regulatory Specialist, you will have the opportunity to work closely with cross-functional teams to develop and implement regulatory strategies that meet global standards. You will maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to our development programs.

You will lead project teams in their awareness of current regulatory best practice when building device development plans. Additionally, you will provide expert advice to the EU regulatory function in relation to the device constituent of drug-device combination products.

This role requires strong technical knowledge of medical device and drug-device combination product regulatory requirements, as well as excellent communication and collaboration skills.

Key Responsibilities:

  • Develop and implement regulatory strategies that ensure compliance with global standards.
  • Maintain awareness of current regulations and regulatory guidance in regions of interest to our development programs.
  • Lead project teams in their awareness of current regulatory best practice when building device development plans.
  • Provide expert advice to the EU regulatory function in relation to the device constituent of drug-device combination products.

Requirements:

  • Bachelor's degree in a scientific/engineering discipline. A master's or higher degree desirable.
  • Proven experience in pharmaceutical and/or medical device development.
  • Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements.
  • Knowledge of global Medical Device and Drug-Device Combination Product quality requirements.
  • Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.

Why Join Us?

We are committed to creating a workplace culture that values diversity, equity, and inclusion. We believe that our unique perspectives and experiences are essential to driving innovation and achieving success.

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