Senior Quality Engineer with 5+yrs experience medical devices regulatory experience required by dynamic multinational in South Dublin. 

Responsibilities:

  • Collaborate with teams and customers to develop and implement regulatory strategies and pathways for medical devices.
  • Provide regulatory advice and guidance throughout the complete product lifecycle.
  • Maintain excellent knowledge of current and emerging global regulatory requirements for the design and marketing of medical devices, medical device software and connected health systems.
  • Create and maintain quality management system procedures to support regulatory and quality compliance.
  • Conduct internal audits and ensure timely follow through on resolution of related audit findings.
  • Provide quality and regulatory related training to new and existing employees.
  • Support certification (e.g. ISO 13485), customer and other regulatory audits.
  • Participate in the evaluation and approval of suppliers.

Essential Requirements:

  • Bachelor’s Degree level in engineering, scientific, or technical discipline.
  • 5+ years of medical device regulatory/quality experience.
  • Good knowledge of medical device software and/or hardware development.
  • Experience working with medical device standards such as ISO 14971, IEC 62304 and IEC 62366.
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to work independently and effectively with minimal supervision.

Ideal Requirements:

  • Planning and preparation of regulatory submissions in EMEA, US and other markets for new products, product changes and re-registrations as required.
  • Validation of automated systems used for GxP activities.
  • Structuring and managing medical device technical files.
  • Medical device post-market surveillance and medical device regulatory reporting.
  • Medical device risk management in accordance with ISO 14971.
  • Experience working with software systems that support regulatory compliance.

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

IND123

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