Senior Project Manager / Delivery Manager – Medical Software

Spyro Soft; Wrocław; On-site; PLN 240,000 - 360,000; Full time

Job summary

Spyro Soft is seeking an experienced Senior Project Manager / Delivery Manager to lead complex, regulated medical software projects within Healthcare & Life Sciences. You will oversee planning, development, QA/V&V, and regulatory documentation to ensure market release for medical devices and SaMD.

The role requires experience with IEC 62304, ISO 13485 and MDR/FDA pathways, and a strong ability to coordinate cross-functional teams across planning, risk management, and regulatory readiness.

Qualifications

• Minimum 5 years of hands-on Project Management / Delivery Management experience in software development projects for medical devices or medical device software.
• Experience with IEC 62304 Software Safety Class A-C projects.
• Experience with full medical software development lifecycle beyond Agile.
• Regulatory submission / conformity assessment and market release experience (EU MDR/CE or FDA pathway).
• Knowledge of ISO 13485 and ISO 14971 in relation to software development.

Responsibilities

• End-to-end delivery of complex medical software development projects.
• Manage project scope, schedule, budget, risks and dependencies.
• Coordinate software development, QA/V&V, and regulatory disciplines to deliver compliant devices.
• Ensure planning, traceability, risk management, verification/validation and documentation.
• Support regulatory submissions, conformity assessment, and audits.
• Lead distributed cross-functional engineering teams and stakeholders.

Skills

Project management

Regulated software development

English proficiency (C1)

Delivery ownership

AI-assisted tools usage

Tools

IEC 62304 knowledge

Job description

We are looking for an experienced Senior Project Manager / Delivery Manager to join our Healthcare & Life Sciences Business Unit and lead complex software development projects for medical device manufacturers.

This is not a generic software project management role. We are looking for someone who understands the realities of delivering software in a regulated medical device environment, from planning and software development, through risk management, verification and validation and regulatory documentation, to successful product release and market access.

Our projects may involve embedded, desktop, cloud, imaging, connected medical devices or Software as a Medical Device (SaMD).

Scope of Services

You will be accountable for:

• end-to-end delivery of complex medical software development projects;
• managing project scope, schedule, budget, delivery risks, dependencies and team capacity;
• ensuring that software development activities are performed in accordance with the agreed medical device software lifecycle and applicable Quality Management System according to the ISO 13485;
• coordinating software development, QA/V&V, Quality & Regulatory and other disciplines required to deliver a compliant medical device product;
• ensuring appropriate planning, traceability, risk management, verification and validation and completeness of required software lifecycle documentation;
• managing projects involving IEC 62304 Software Safety Class A-C software;
• supporting preparation and readiness of project documentation required for regulatory submissions, conformity assessment and audits;
• working closely with clients, including senior technical, product, quality and regulatory stakeholders;
• leading distributed, cross-functional engineering teams;
• identifying delivery and regulatory risks early and driving mitigation actions;
• managing changes to requirements and scope in a controlled environment;
• supporting estimations, project planning, commercial discussions and preparation of Statements of Work;
• continuously improving delivery processes and ways of working;
• using modern AI tools to improve project management, analysis, documentation, communication and operational efficiency while maintaining appropriate confidentiality, quality and human oversight.

Required Qualifications

Must have

• Minimum 5 years of hands-on Project Management / Delivery Management experience in software development projects for medical devices or medical device software.
• Proven experience managing software development according toIEC 62304, including direct experience with at least oneSoftware Safety Class C project.
• Experience with thefull medical software development lifecycle, not limited to agile delivery or software implementation.
• Proven participation in at least one project that successfully progressed through regulatory submission / conformity assessment and resulted in product market release in:
  • the European Union underMDR / CE marking, and/or
  • the United States through an applicableFDA pathway.
• Practical understanding of medical device Quality Management Systems andISO 13485.
• Practical understanding of medical device risk management according toISO 14971 and its relationship with software development and software risk controls.
• Experience managing software lifecycle documentation, requirements, traceability, verification and validation evidence and release readiness in a regulated environment.
• Strong project and delivery management capabilities covering scope, budget, forecasting, planning, dependencies, risks and change management.
• Experience working directly with customers and senior stakeholders.
• Experience leading distributed and cross-functional engineering teams.
• Good understanding of Agile development practices as well as regulated / plan-driven development models. Ability to adapt the delivery model to project and regulatory needs rather than applying one methodology mechanically.
• Strong practical use ofAI-assisted tools in everyday professional work, including areas such as information analysis, documentation, reporting, project planning, risk analysis, meeting follow-up and workflow automation.
• Ability to critically evaluate AI-generated outputs and use AI appropriately in environments involving confidential and regulated information.
• Excellent communication, negotiation and stakeholder-management skills.
• Fluency in English, minimum C1 level.

Nice to have

• Experience with bothEU MDR and FDA-regulated products.
• Experience interacting with Quality Assurance, Regulatory Affairs, auditors, Notified Bodies or FDA-related submission activities.
• Knowledge of additional medical device standards and guidance, such as IEC 62366-1, IEC 81001-5-1 or related cybersecurity requirements.
• Experience with SaMD, connected medical devices, medical imaging, diagnostic software or other safety-critical healthcare systems.
• Experience delivering projects under different commercial models, including Time & Material and Fixed Price.
• Experience in presales, project estimation, proposal preparation and client workshops.
• Technical or engineering background enabling effective cooperation with software architects and engineering teams.

What we are looking for

We are looking for someone who can combine strong delivery ownership with an understanding of regulated medical software development.

The ideal expert is comfortable discussing project economics and delivery risks with management, software architecture and dependencies with engineering teams, and regulatory readiness, evidence and documentation with Quality and Regulatory stakeholders.

Most importantly, we are looking for someone who has already experienced what it takes to bring medical software from development through the regulated lifecycle to an actual market release — and can confidently lead others through that process.