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- Tasks: Lead exciting projects in quality systems and medical device compliance, ensuring timely delivery and stakeholder satisfaction.
- Company: Join a specialized tech company focused on innovative solutions in the medical device sector.
- Benefits: Enjoy remote work flexibility and the opportunity for contract-to-hire positions.
- Why this job: Be part of a dynamic team driving digital transformation and compliance in healthcare technology.
- Qualifications: Expertise in quality management systems and regulatory compliance is essential; experience in medical devices is a plus.
- Other info: This role offers a chance to mentor teams and implement cutting-edge solutions in a collaborative environment.
The predicted salary is between 36000 - 60000 £ per year.
Project Manager – Quality Systems & Medical Device Compliance
Job Type: Contract to Hire
Location: London (Remote / Paddington)
Job Ref: BBBH157687_1739529186
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.
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Project Manager - Quality Systems & Medical Device Compliance. employer: Lorien
Contact Detail:
Lorien Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Project Manager - Quality Systems & Medical Device Compliance.
✨Tip Number 1
Familiarize yourself with the specific regulatory standards mentioned in the job description, such as ISO 13485 and FDA 21 CFR. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance in the medical device industry.
✨Tip Number 2
Highlight your experience with Quality Management Systems (QMS) and any relevant software tools like SAP QM or TrackWise. Be prepared to discuss specific projects where you successfully implemented these systems, as this will showcase your hands-on expertise.
✨Tip Number 3
Network with professionals in the medical device field, especially those who have experience in project management and compliance. Engaging with industry groups or attending relevant webinars can provide valuable insights and connections that may lead to opportunities.
✨Tip Number 4
Prepare to discuss your approach to risk and issue management during the interview. Share examples of how you've identified potential risks in past projects and the strategies you employed to mitigate them, as this is a key responsibility for the role.
We think you need these skills to ace Project Manager - Quality Systems & Medical Device Compliance.
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and skills required for the Project Manager position. Tailor your application to highlight your relevant experience in quality systems and medical device compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your expertise in process optimization, regulatory applications, and leading quality/compliance projects in medical devices. Use specific examples that demonstrate your success in managing similar projects.
Showcase Stakeholder Engagement Skills: Since the role involves working closely with cross-functional teams, make sure to illustrate your experience in stakeholder engagement. Provide examples of how you've effectively communicated and collaborated with various teams to achieve project goals.
Focus on Compliance Knowledge: Given the importance of compliance in this role, detail your knowledge of relevant regulations such as ISO 13485, FDA 21 CFR, and EU MDR. Mention any specific projects where you ensured adherence to these standards.
How to prepare for a job interview at Lorien
✨Understand the Project Lifecycle
Make sure you can clearly articulate your experience with managing the end-to-end project lifecycle, especially in software projects. Be prepared to discuss specific examples where you delivered projects on time, within scope, and on budget.
✨Showcase Stakeholder Engagement Skills
Highlight your ability to work closely with cross-functional teams. Prepare to share instances where you acted as a liaison between technical teams and business units, ensuring that requirements were accurately captured and delivered.
✨Demonstrate Compliance Knowledge
Familiarize yourself with regulatory requirements and industry standards relevant to medical devices, such as ISO 13485 and FDA regulations. Be ready to discuss how you've ensured compliance throughout the project lifecycle in your previous roles.
✨Prepare for Risk Management Questions
Think of examples where you identified potential risks and developed mitigation strategies. Be prepared to explain how you resolved project issues effectively to minimize disruption to business operations.
