Strategic Regulatory Compliance Officer

4 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €103,124 - €121,796
Job Description:

The Senior Regulatory Affairs Specialist will be responsible for developing regulatory strategies and overseeing the activities necessary to obtain and maintain approval to commercialize medical devices in target markets. This involves close collaboration with regulatory affairs management and other departments.

Key Responsibilities:
  • Maintain an in-depth understanding of global medical device regulations, focusing on FDA guidance and MDD 93/42/EEC.
  • Develop comprehensive regulatory plans for the company.
  • Prepare and coordinate regulatory submissions, particularly for US FDA clearances (510(k), HDE, IDE, PMA).
  • Communicate effectively with regulatory authorities to ensure timely product approvals.
Requirements:

To succeed in this role, you will need:

  • A minimum of 5 years' experience in Regulatory Affairs, Design Assurance, or a similar position in a medical device company.
  • Primary and/or postgraduate degree in Mechanical, Materials, Polymer, Biomedical Engineering, or a related technical field.
  • Demonstrated knowledge and practice of risk management methodologies as per EN ISO14971.
  • Working knowledge of FDA requirements (Quality System Regulation, 21 CFR 820) and applicable harmonized standards.

This is a permanent position located in Galway, Ireland.

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