Senior Regulatory Affairs Specialist

3 days ago

Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €60,000 - €90,000

Seeking a Senior Regulatory Affairs Professional with expertise in developing regulatory strategies and obtaining approval for medical device commercialization.

The ideal candidate will possess a deep understanding of global medical device regulations, including FDA guidance and MDD 93/42/EEC. They will collaborate with regulatory affairs management to develop strategic plans and prepare regulatory submissions, such as 510(k), HDE, IDE, and PMA submissions. Additionally, they will communicate effectively with regulatory authorities to ensure timely product approvals.

  • Maintain comprehensive knowledge of global medical device regulations and guidelines
  • Develop and implement regulatory strategies to support medical device commercialization
  • Prepare and submit regulatory documents, including 510(k) and PMA submissions
  • Collaborate with cross-functional teams to achieve regulatory objectives
Requirements:
  • Minimum 5 years' experience in Regulatory Affairs or related field
  • Primary degree in Mechanical, Materials, Polymer, or Biomedical Engineering or related technical field
  • Knowledge of risk management methodologies as per EN ISO14971
  • Working knowledge of FDA requirements, including Quality System Regulation (21 CFR 820)

This is a permanent role within a small medical device company in Galway, offering the opportunity to work on exciting projects and contribute to the development of innovative products.

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