Regulatory Affairs Manager

5 days ago


Dublin, Dublin City, Ireland TN Ireland Full time

This is a rare opportunity to join TN Ireland, a clinical-stage biotechnology company focused on discovering and developing novel therapies for debilitating diseases. The company has experienced rapid growth in 2023.

Job Overview:

The Senior Director Regulatory Affairs Device will lead key elements of regulatory systems, ensuring compliance with relevant standards for medical devices including ISO 13485 and FDA QSR. This role involves defining the device regulatory strategy and overseeing all device submissions across global markets.

Key Responsibilities:
  1. Define the global regulatory strategy for medical device products in partnership with cross-functional teams.
  2. Plan, submit and maintain technical files and regulatory dossiers for clinical trial and marketing applications.
  3. Lead planning and execution of regulatory agency meetings/communications and scientific advice processes.
  4. Manage CE Marking of medical devices, including notified body selection, QMS audits and technical file compilation and audit.
Requirements:
  • Bachelors or Graduate degree qualification in Science, Engineering or related field.
  • 10+ years experience in medical device/combination product development and regulatory affairs.
  • Proven experience with small molecule/biologic drug development in the context of drug/device combination products.
  • Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820, and FDA QSRs required.


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