Job Description
Company Description The Quality Assurance & Regulatory Officer (QARO) plays a hands-on role within ELEM’s Quality and Regulatory Affairs.
ELEM is a cutting‑edge in silico startup developing virtual human digital twin technology to transform the future of healthcare. As part of our Compliance team, the QARO ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements.
Quality Control, Non‑Conformities & Continuous Compliance: Handle non‑conformities and deviations end‑to‑end, including documentation, investigation, and root cause analysis. Define, implement, and routinely monitor quality controls throughout the product lifecycle. Review and confirm that manufactured software versions meet conformity requirements before market release.
Document Control, Traceability & Complaint Handling: Manage traceability, storage, and controlled handling of quality documents and complaints.
Regulatory Monitoring & ...
ELEM is a cutting‑edge in silico startup developing virtual human digital twin technology to transform the future of healthcare. As part of our Compliance team, the QARO ensures that our solutions, processes, and documentation meet all applicable quality and regulatory requirements.
Quality Control, Non‑Conformities & Continuous Compliance: Handle non‑conformities and deviations end‑to‑end, including documentation, investigation, and root cause analysis. Define, implement, and routinely monitor quality controls throughout the product lifecycle. Review and confirm that manufactured software versions meet conformity requirements before market release.
Document Control, Traceability & Complaint Handling: Manage traceability, storage, and controlled handling of quality documents and complaints.
Regulatory Monitoring & ...
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