About this role
Contract Software Project Manager leading software integration programs for acquisitions within a regulated medical device environment.
Key Responsibilities
- Lead planning and execution of complex software development and integration programs associated with acquisitions
- Partner with cross-functional teams to align legacy and acquired processes
- Develop integrated program plans covering software development, verification and validation, cybersecurity and regulatory deliverables
- Manage schedules, budgets, risks, and interdependencies
- Provide data-driven status to leadership
Technical Overview
Focus on regulated software development lifecycles (IEC 62304, ISO 14971, ISO 13485), regulatory expectations (FDA, EU MDR), and SaMD/SiMD; involves cross-functional leadership across R&D, Quality, Regulatory, IT, and Cybersecurity.
Ideal Candidate
The ideal candidate is a mid-level software project manager with 8+ years in regulated medical device contexts, capable of leading acquisition integrations and ensuring regulatory compliance across IEC 62304, ISO 14971, and ISO 13485.
Must-Have Skills
Bachelor's degree in engineeringcomputer science or a related technical disciplineMinimum of 8 years' experience in program or project management within the medical device industryor other regulated industriesDemonstrated experience leading cross-functional software development programsStrong understanding of regulated software development lifecycles and quality systemsProven ability to manage complexambiguous programs with multiple stakeholders
Nice-to-Have Skills
Experience supporting mergersacquisitions or technology integrationsFamiliarity with FDAEU MDR and global regulatory expectations for software in a medical device (SiMD)/Software as a Medical Device (SaMD)Experience with cybersecuritycloud-connected devices or mobile health platformsPMPPgMPAgile or SAFe certificationMaster's degree in engineeringmanagement or a related field
Required Skills
Bachelor's degree in engineeringcomputer science or related technical discipline8+ years PM in regulated industriescross-functional leadershipregulatory lifecycle knowledgeIEC 62304ISO 14971ISO 13485FDAEU MDRSiMDSaMDacquisitions experienceregulatory submissionsverification and validationcybersecurityAgile/SAFe
Hard Skills
Project ManagementProgram ManagementSoftware Development LifecycleIEC 62304ISO 14971ISO 13485FDAEU MDRSiMDSaMDMergers & AcquisitionsRegulatory submissionsVerification and validationCybersecurityCloud-connected devicesMobile health platformsPMPPgMPAgileSAFe
Soft Skills
Cross-functional collaborationStrong communicationLeadershipStrategic thinkingProblem solving
Certifications
Preferred
PMPPgMPSAFe CertificationAgile Certification
Keywords for Your Resume
software project managerprogram managementmedical deviceIEC 62304ISO 14971ISO 13485FDAEU MDRSiMDSaMDregulatory submissionsverification and validationcybersecuritycloud-connected devicesmobile healthcross-functional teamsR&Dquality systemsacquisitionsmergers and acquisitionstravel up to 25%PMPPgMPSAFeAgile
Deal Breakers
Lack of 8+ years PM experience in regulated industries, No experience with IEC 62304, ISO 14971, ISO 13485, Unwillingness to travel up to 25%
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile