Project Manager – Remediation & Compliance (Contract)
- Location: Galway (Hybrid – 3–4 days onsite preferred)
- Contract: 12 Months
- Industry: Medical Devices
The Opportunity
We are partnering with a leading medical device company to hire a Project Manager to support critical product and process remediation programmes. This is an ideal opportunity for someone with experience delivering cross-functional projects in a highly regulated environment, particularly around CAPA, compliance, inspection readiness, quality systems, and remediation initiatives.
You will coordinate multiple workstreams, drive project execution, manage risks and dependencies, and ensure remediation commitments are delivered on time while partnering with Quality, Engineering, Operations, Regulatory Affairs, Manufacturing and R&D teams.
Key Responsibilities
Project Management & Governance
- Develop and maintain integrated project plans, schedules and milestone trackers.
- Coordinate cross-functional remediation activities across multiple workstreams.
- Manage risk registers, issue logs, action trackers and dependency plans.
- Facilitate project meetings and ensure actions and decisions are documented.
- Prepare project updates and governance reports for senior stakeholders.
- Drive accountability for timely completion of project deliverables.
Remediation & Compliance
- Coordinate product and process remediation activities from assessment through implementation.
- Track corrective actions, gap assessments and remediation commitments.
- Support Design Control, Risk Management, DHF and Process Validation remediation projects.
- Partner with Quality teams to drive CAPA implementation and quality system improvements.
- Ensure project documentation aligns with regulatory and quality requirements.
Inspection Readiness
- Support audit and inspection readiness programmes.
- Coordinate compliance actions, responses and deliverables.
- Monitor progress of audit observations and remediation commitments.
- Escalate risks or delays that may impact regulatory readiness.
What We're Looking For
Essential
- Bachelor's degree in Engineering, Science, Project Management or a related discipline.
- 3+ years' experience managing projects within a regulated medical device, pharmaceutical or life sciences environment.
- Experience supporting remediation, compliance, CAPA or inspection readiness initiatives.
- Strong project planning and stakeholder management skills.
- Proven ability to manage risks, dependencies and multiple priorities simultaneously.
- Excellent communication and cross-functional coordination abilities.
Desirable
- Knowledge of Quality Systems, Design Controls, Risk Management and Process Validation.
- Experience with Design History File (DHF) remediation.
- Familiarity with FDA, ISO 13485 or other regulated quality frameworks.
- Experience using Microsoft Project, Smartsheet or similar project management tools.
- PMP or formal project management certification.
