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Regulatory Technical Project Engineer
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Full-time
- Devise and deliver future strategies to remedy technical risks/issues which threaten product supply.
- Perform all activities in compliance with current legislation, regulation, regulatory guidance, professional codes of practice and accrediting standards as well as the Alliance Quality Management System, policies, processes and internal code of practice.
- Examples of technical projects include transfer of production between manufacturing locations, stability/shelf-life testing, line extension projects, regulatory compliance testing, process validation, material/pack changes, sourcing activities or technical support for quality investigations and evaluations.
- Applied experience in a technical, clinical research, or compliance function within a US FDA regulated environment – preferably Medical Device or Pharmaceuticals.
- Willing to work in a hybrid working environment (in-person and remote) across multiple global time zones.
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