Project Manager - Quality Systems & Medical Device Compliance.

Project Manager - Quality Systems & Medical Device Compliance

Job Type: Contract to Hire

Location: London (Remote / Paddington)

Job Ref: BBBH86

Date Added: February 14th, 2025

Consultant: Louis Poynter

My client, a specialised technology company, is looking to recruit a Project Manager for Quality Systems and Medical Device Compliance to join them on an initial 6-month contract, working with their team based in London Paddington. The Project Manager will focus on the implementation of small, medium, and large projects including key digital systems.

Key Responsibilities:

• Lead end-to-end project lifecycle for software projects, ensuring delivery on time, within scope, and on budget.
• Manage multiple projects simultaneously, prioritising resources and efforts effectively.
• Define project objectives, milestones, and success criteria in collaboration with stakeholders.
• Ensure authorised projects have the appropriate resources and funding assigned to them.
• Stakeholder Engagement: Work closely with cross-functional teams, including Global Marketing & Sales, regulatory, IT, and external vendors. Act as the primary liaison between technical teams and business units to ensure requirements are accurately captured and delivered.
• System Implementation: Oversee the implementation of software, ensuring integration with existing platforms and compliance with data security standards. Manage the development and enhancement of company websites, ensuring they meet accessibility, usability, and branding standards. Ensure release procedures and appropriate governance are adhered to.
• Compliance and Data Privacy: Ensure adherence to regulatory requirements, corporate policies, and industry standards throughout the program lifecycle. Oversee the deployment of customer consent management systems to ensure data privacy compliance.
• Risk and Issue Management: Identify potential risks and proactively develop mitigation strategies. Resolve project issues in a timely and effective manner to minimize disruption to business operations. Mentor and guide project teams, fostering a collaborative and results-oriented environment. Evaluate performance metrics and implement continuous improvement practices for programme delivery.

Key Skills and Experience:

• Expertise in process optimization and regulatory application implementations.
• Leading quality/compliance projects in medical devices, including ISO 13485, FDA 21 CFR, EU MDR.
• Expert in Quality Management Systems (QMS) deployments (e.g., SAP QM, TrackWise) for audit readiness and CAPA workflows.
• Led remediation projects.
• Experience with DHF, DMR, Technical Files.
• Experience with 21 CFR Part 11 compliance for electronic records/signatures in ERP, LIMS, and MES systems (e.g., Siemens Teamcenter, Pilgrim SmartSolve).
• Directed validation projects (IQ/OQ/PQ) for manufacturing software, lab equipment, and IoT-enabled medical devices.
• Integrated post-market surveillance tools (e.g., Agile PLM) for adverse event reporting and trend analysis.
• Streamlined supplier quality processes via SAP SRM, ensuring compliance with ISO 9001 and supplier audit protocols.
• Piloted AI/ML solutions for predictive quality analytics and automated non-conformance reporting.
• Bridging quality compliance with digital transformation (QMS).
• Cross-functional leadership of RA, QA, R&D, and manufacturing teams.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.