Senior Project Manager leading projects in medical devices with compliance and quality assurance. Collaborating with cross-functional teams to ensure timely delivery and regulatory adherence.
Responsibilities
Lead end-to-end delivery of medical device projects, ensuring compliance with regulatory and quality standards
Manage scope, timelines, budget, risks, and stakeholder expectations in a regulated healthcare environment
Coordinate with quality and regulatory teams to ensure adherence to industry standards and certification processes
Guide multidisciplinary teams across software, hardware, and systems engineering
Ensure clear, structured communication across clients, internal teams, and leadership
Drive risk management, traceability, and documentation aligned with medical device requirements
Support continuous improvement and adoption of best practices in medical device development lifecycles
Mentor team members and foster a culture of quality, safety, and excellence
Contribute to business development activities within the medical devices domain, supporting client relationships and growth
Requirements
5+ years (ideally 7+) of experience managing complex projects, with a strong focus on medical devices
Proven experience working within regulated environments (e.g., IEC 62304, ISO 13485, FDA, MDR)
Strong leadership and decision-making skills in safety-critical contexts
Experience managing cross-functional teams including software, quality, and regulatory experts
Excellent communication skills with the ability to engage technical and non-technical stakeholders
Strong problem-solving mindset and risk management capabilities
Experience delivering projects using Agile, Waterfall, or Hybrid methodologies
Experience managing international or multi-site projects
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