Senior Regulatory Affairs Specialist with good understanding of ISO 13485 and FDA QSR quality standards required for key role with growing medical devices company in Galway. 

Requirements: 

  • Bachelor’s Degree (Hons) in Quality/Regulatory or related discipline
  • 3-5+ years practical and relevant experience in Regulatory Affairs, medical device preferable
  • Good understanding of ISO 13485 and FDA QSR quality standards
  • Excellent verbal and written communication skills
  • Excellent attention to detail 
  • “Self-starter” in terms of time and task management, and be able to operate with minimal supervision
  • Possess strong Technical Writing ability.
  • Have a methodical review approach, and be capable of initiating and leading change and continuous improvement
  • Ability to work within a team environment to achieve agreed company goals

Key Responsibilities:

  • Assist in defining the regulatory strategy for individual devices within the Product Development Process
  • Assist in the management of the CE mark Submissions / Significant Changes and Notified Body interactions
  • Assist with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions
  • Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies
  • Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed
  • Participate in Notified Body / Regulatory Agency audit preparation and follow up
  • Assist in identifying and initiating required action(s) to address any adverse trends or regulatory compliance issues

    
emer@emtechrecruitment.ie

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