Chief Device Assurance Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeCompliance Full time
Device Development Assurance Role

We are seeking a highly skilled Device Development Assurance Scientist/Engineer to join our team. This role will be responsible for ensuring the development of devices meets the highest standards of quality and compliance.

  • Support and provide guidance for device development programs through the design and development lifecycle for Combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices.
  • Establish, maintain and provide guidance on the contents of Design History Files for development programs, for various program types – in-house design authority, collaborative development, and acquired programs.
  • Collaborate with, and influence, affiliate sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
Required Skills and Qualifications

To be successful in this role, you will need:

  • A degree in engineering or science/life science.
  • Industry experience in Medical Device or Pharmaceutical (with devices).
  • 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.
Benefits

We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

  • Excellent career progression opportunities.
  • Work-life balance initiatives.
  • Bonus scheme.
  • Health insurance.
About Us

We are a global healthcare company dedicated to building a truly diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.

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