Software Project Lead for Regulated Diagnostics

Hira Ni

United Kingdom

Remote

GBP 60,000 - 80,000

Full time

8 days ago

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Job summary

Randox Laboratories in Crumlin, Northern Ireland, invites applications for an experienced Software Development Project Manager. You will drive end-to-end software initiatives powering diagnostic platforms, balancing innovation with regulatory rigor, in collaboration with engineering, data science, quality and regulatory teams.

Lead schedules, resourcing, risk management, and delivery roadmaps while ensuring compliance with FDA, ISO 13485, IEC 62304 and privacy rules.

Qualifications

Degree in engineering/CS/required field or equivalent experience.
Strong communication and organisational skills essential.
Experience coordinating cross-functional teams in regulated environments.

Responsibilities

End-to-end delivery of software projects from scoping to release.
Create and own schedules, resource plans, risk registers, and roadmaps.
Coordinate across software engineering, QA, data science, systems engineering, quality, and regulatory teams.
Align development with FDA, ISO 13485, IEC 62304, CLIA and privacy regulations.
Facilitate Agile or hybrid delivery models for regulated product development.
Track milestones, dependencies, risks, and communicate progress to stakeholders.
Support verification, validation and documentation for audits and submissions.
Oversight of change control, issue triage and release readiness.