Senior Regulatory Affairs Specialist

24 hours ago

Limerick, Limerick, Ireland beBeeRegulatory Full time
Regulatory Strategy Lead

This is a permanent role with full benefits including bonus, pension and healthcare for employee and their family.

Main Responsibilities:

  • Assess global trends, stakeholder concerns and regulatory issues to inform strategy
  • Develop and update global, regional and multi-country regulatory strategy
  • Provide guidance to integrate regulatory considerations into product entry and exit strategy
  • Analyze proposed regulatory pathways and recommend changes or refinements
  • Assess market access and distribution requirements and develop solutions to address obstacles
  • Negotiate with regulatory authorities on complex issues
  • Establish relationships with government and non-government organizations
  • Identify the need for new regulatory procedures and manage their development and execution
  • Train stakeholders on current and new regulatory requirements
  • Provide strategic input on global regulatory requirements
  • Evaluate risks of product and clinical safety issues
  • Review and assess proposals to regulatory authorities
  • Monitor implementation of regulatory strategies
  • Provide regulatory guidance on strategy for proposed product claims/labeling
  • Ensure data are consistent with regulatory requirements
  • Lead key negotiations and interactions with regulatory authorities

Requirements:

  • BS in science, engineering or related field, Advanced degree preferred
  • Minimum 8 years experience, People Management experience required

About Stryker:

Stryker is a global leader in medical technologies driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Stryker impacts more than 150 million patients annually.

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