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