Regulatory Compliance Expert

5 days ago

Dublin, Dublin City, Ireland beBee Careers Full time €60,000 - €80,000
Regulatory Specialist Position

This exciting opportunity is ideal for a highly motivated and detail-oriented individual with a strong background in Regulatory Affairs. As a Regulatory Specialist, you will play a critical role in championing compliance to applicable global regulations and standards.

Key Responsibilities:

  • Ensure products comply with regulatory requirements in current markets and work with non-compliant suppliers.
  • Maintain an audit-ready product database for customers and HPRA assurance.
  • Organize and update regulatory files, records, and documentation for internal and external stakeholders.
  • Support regulatory agency audits, inspections, and interactions, including document requests and responses.
  • Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes.
  • Monitor the impact of changing global regulations on submissions, guidance documents, and best practices.
  • Drive a quality culture in accordance with our quality policies, guidelines, and processes.
  • Work with the Commercial Team to ensure country-specific registration activities are understood and addressed.
  • Lead Management Review processes and report on the performance of the Quality System.
  • Manage Design Control, Change Control, CAPA, Risk Management, Product Vigilance, and Document Control Systems.
  • Lead strategic quality improvement projects and initiatives to enhance long-term sustainability.
  • Evaluate and authorize changes to supply chain processes.
  • Lead product and facility inspections, including preparation of procedures and instructions, certification assessments, surveillance audits, and inspections by regulatory bodies.

Requirements:

  • A minimum of 3 years' experience in a medical device/healthcare industry regulatory position.
  • Excellent attention to detail, time management skills, and ability to operate with minimal supervision.
  • A methodical review approach and capability to initiate and lead change and continuous improvement.
  • Ability to work within a team environment to achieve company goals.
  • Good understanding of ISO, MDD, MDR, CE/UKCA standards.
  • Analytical mindset and critical thinking skills.
  • Excellent communication and interpersonal skills.

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