Senior Global Regulatory Affairs Specialist required by innovative medical devices multinational in West Dublin.  You will prepare and project-manage high quality device registrations for approval by the US Food & Drug Administration and EU Competent Authorities.

Responsibilities:

  • Functions under direction to address and implement tactical direction for device issues
  • Effectively interacts with cross-functional project teams to meet project goals
  • Works closely with devices RA team to achieve RA and business goals
  • Under direction, performs activities to support assigned products to implement regulatory strategies to secure global device licenses and approvals
  • Under direction, assembles the content of global regulatory dossiers
  • Implements regulatory policy and strategy for assigned products
  • Contributes to preparation and maintenance of risk assessment and mitigation strategy development for assigned products
  • Implements plans for alignment of regulatory strategy and business objectives
  • Investigates issues and prepares post-filing communications and deliverables
  • Member of project team to deliver required regulatory contributions to meet business needs
  • Remains abreast of modifications/variations in regulatory plans
  • Works with manager to ensure regulatory strategy is developed for all key issues for assigned products
  • Develops and expands knowledge of the regulatory environment in areas of commercial interest and its impact on regulatory strategy and implementation
  • Under direction, prepare IDEs, 510(k)s, PMAs
  • Participates in educational and business activities leading to basic knowledge of the therapeutic area

Requirements:

  • Level 8 Science / Engineering Degree
  • Excellent working knowledge of the USA and EU regulatory requirements and procedures
  • Experience in the preparation of relevant technical, safety and performance technical documents to support submissions
  • Quality control review of technical/ regulatory documents
  • Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
  • Compliance with SOPs, Change controls and regulatory best practices
  • Familiarity with electronic submissions (eCTD) useful 
  • Familiar with MS Office, or equivalent, etc.
  • Excellent written and oral communication skills required
  • Attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage
  • Project management experience – an advantage
  • Hardworking, self-motivated and with attention to detail

Please contact Emer Smith to discuss in confidence

00353578638188

emer@emtechrecruitment.ie 

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