Device Development Assurance Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €80,000 - €95,000

Job Title: Device Development Assurance Specialist
This role is responsible for ensuring compliance with design control requirements and international device standards in the development of medical devices and combination products.
The successful candidate will have a strong understanding of quality management systems, regulatory requirements, and industry best practices.

About the Job

The Device Development Assurance Specialist will work closely with cross-functional teams to ensure that device development programs meet regulatory requirements and are delivered on time. This includes:

  • Developing and maintaining design history files for development programs
  • Collaborating with affiliate sites and third parties to ensure compliance with design control requirements
  • SUPPORTING THE INTEGRATION OF ACQUIRED PRODUCTS INTO THE GLOBAL DEVICE DEVELOPMENT PRODUCT PORTFOLIO
  • Implementing risk management activities for development programs
  • Participating in audits and health authority submissions
Requirements

To be successful in this role, you will need:

  • A degree in engineering or science/life science
  • Proven experience in device development and manufacturing operations
  • Strong knowledge of design controls, ISO 13485, and FDA regulations
  • Excellent problem-solving and analytical skills
  • Ability to communicate effectively with external and internal partners
Benefits

We offer a competitive salary, excellent career progression opportunities, and a bonus scheme. Our benefits package also includes health insurance, pension, and work-life balance initiatives.

About Us

We are a global company dedicated to building a diverse, inclusive, and authentic workplace. We believe in creating better health for a better world, one person at a time.

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