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Senior Regulatory Affairs Specialist *100% REMOTE*

Job description

Senior Regulatory Affairs Specialist ****100% remote within Ireland****

You will be supporting and sustaining of products on the market in compliance with all regulatory requirements

Responsibilities:

  • Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
  • Recommends strategies for earliest possible approvals of clinical trials applications
  • Keeps abreast of regulatory procedures and changes
  • Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed
  • Teams with business unit Regulatory Affair Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies

Experience:

  • Bachelors’ degree required (Level 8)
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Experience in Medical device and/or Pharma is essential
  • Works directly on regulatory files for USA / EU.  Experience working directly with FDA, notified bodies in the European Union and International Regulators preferred
  • Experience working with Class III medical devices
  • Experience with product change control
  • Knowledge of new Medical Device Regulation in European Union
  • Lead projects/programs on own initiative
  • Proficient with Microsoft applications including, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable

 

To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E:   koshea@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

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