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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and operationalizing connected medical devices and digital health solutions, with a strong focus on respiratory clinical trials and regulatory compliance. Proven ability to manage complex projects, lead cross-functional teams, and communicate effectively with stakeholders.
Highest-signal resume keywords
Respiratory Clinical Trials ExperienceDigital Health Solutions ExpertiseFDA Guidelines KnowledgeAdvanced Project Management SkillsLeadership in Cross-Functional Initiatives
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Connected Medical DevicesRegulatory ComplianceOperational WorkflowsValidation ApproachesBusiness Case DevelopmentRisk ManagementBudget ManagementSolution DesignTroubleshooting GuidanceQuality Management
Soft Skills
Strong Communication SkillsStakeholder ManagementExecutive-Level Presentation SkillsRelationship BuildingProcess Improvement
Industry Keywords
HealthcarePharmaceuticalLife SciencesDigital HealthEMEA
Tech Stack
Tools & technologiesGo
About the role
Key responsibilities & impact- Serve as the end-to-end execution owner and subject-matter expert for developing, validating, and operationalizing connected medical device and digital health solutions
- Partner with Strategic Solutions Leads to evaluate, shape, and deliver solution offerings aligned with Connected Devices strategy, primarily supporting the respiratory service line
- Provide subject-matter expertise on solution feasibility, operational workflows, regulatory considerations, validation approaches, business cases, budgets, go-to-market strategy, and customer presentations
- Own execution of approved solutions from business case approval through Business Go-Live
- Develop and manage startup plans, milestones, dependencies, risks, constraints, and mitigation strategies
- Ensure solution design, operational workflows, and validation activities align with study, program, and stakeholder needs
- Confirm readiness at each startup stage and before Business Go-Live
- Lead and coordinate Engineering, IT, Validation, QA, Regulatory, Data Management, Operations, Logistics, Vendors, Field Support, and Training
- Translate solution concepts into device, system, service, and validation requirements
- Support vendor relationships, issue resolution, design alignment, and budget collaboration
- Provide troubleshooting guidance and engage with sites and customers to resolve complex issues
- Ensure documentation, validation, training, support models, and escalation pathways are ready
- Partner with Solution Specialists on regulatory and compliance requirements
- Lead quality management, process improvement, and continuous improvement initiatives
- Contribute to SOPs, study templates, and site/patient-facing materials
- Own startup-level issue resolution and escalate scope, timeline, investment, or delivery risks appropriately
- Communicate startup status, risks, and readiness to stakeholders, sponsors, and leadership
- Transfer ownership at Business Go-Live to study execution leadership while retaining solution-level escalation/support responsibilities
Requirements
What you’ll need- Experience supporting respiratory clinical trials (e.g., asthma, COPD, pulmonary indications) is required
- Strong knowledge of digital health, connected medical devices, and regulated clinical environments
- Working knowledge of FDA guidelines and global regulatory expectations and their operational impact
- Advanced project and program management skills in complex, matrixed organizations
- Excellent technical aptitude related to systems, platforms, integrations, and device workflows
- Strong communication, stakeholder management, and executive-level presentation skills
- Proven ability to establish and maintain effective working relationships with internal teams, vendors, sponsors, sites, and clients
- Bachelor’s degree or equivalent combination of education, training, and experience
- 10+ years of relevant experience in healthcare, pharmaceutical, life sciences, or digital health environments
- Demonstrated leadership experience managing people, operations, and cross-functional initiatives
- Strong business acumen with experience supporting solution development, commercialization, and delivery
- Candidates must currently reside in EMEA
- Candidates without direct respiratory trial experience clearly demonstrated within their resume will not be considered
Benefits
Comp & perks- Remote opportunity
- Occasional travel may be required
- Opportunity to work on innovative connected medical device and digital health solutions
- Diversity, inclusion, and belonging culture