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Device Assurance Specialist
2 weeks ago
This role is focused on guaranteeing adherence to design control requirements during medical device development. You will collaborate closely with cross-functional teams to develop innovative device technologies for drug delivery.
- Provide guidance on Design History Files and associated activity plans and timelines.
- Collaborate with stakeholders to establish objective evidence and controls.
- Support integration and assess compliance of acquired combination products and medical devices into the Global Device Development portfolio.
- Maintain awareness of industry best practices and implement improvement actions.
- Participate in audits, including health authority and certification body audits.
About This Role:
- You require a degree or masters in engineering or science/life science.
- Proven experience in similar roles/general experience in the medical device or pharmaceutical industry.
- Demonstrated understanding of GMP, Quality Management System, and relevant regulations and international standards.
- Strong problem-solving and analytical skills, with excellent communication and teamwork abilities.