Device Development Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €100,000 - €150,000
Job Overview

The Principal Device Development Assurance Scientist/Engineer plays a critical role in ensuring the design and development of combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices comply with regulatory requirements outlined in quality management systems.

This involves establishing and maintaining design history files for development programs, collaborating with affiliate sites, and influencing third-party partners to ensure compliance.

  • Supporting device development programs through the design and development lifecycle
  • Ensuring compliance with regulatory requirements outlined in quality management systems
  • Establishing, maintaining, and providing guidance on design history files
  • Collaborating with affiliate sites and third-party partners
  • Assessing compliance with regulatory requirements for acquired combination products and medical devices
Key Responsibilities

The successful candidate will be responsible for:

  1. Designing and developing medical devices that meet regulatory requirements
  2. Collaborating with cross-functional teams to develop and implement design control processes
  3. Providing technical expertise to support the development of medical devices
  4. Conducting audits and assessments to ensure compliance with regulatory requirements
  5. Developing and implementing training programs to ensure compliance with regulatory requirements
Requirements

To succeed in this role, you will need:

  • Education: Degree or Master's in engineering or a related field
  • Industry experience in medical device or pharmaceutical manufacturing
  • Proven experience in similar level/general experience in industry
  • Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
  • Strong problem-solving and analytical skills
  • Excellent communication skills and ability to work flexibly across a multi-disciplinary team

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