Connected Devices – Solution Implementation Lead

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Act as the primary execution lead and subject-matter authority for the development, validation, and implementation of connected medical devices and digital health solutions.

• Collaborate with Strategic Solutions Leads to assess, shape, and deliver solution offerings in alignment with the Connected Devices strategy, with a focus on the respiratory service line.

• Offer subject-matter expertise regarding solution viability, operational workflows, regulatory considerations, validation methods, business cases, budgets, go-to-market strategies, and customer presentations.

• Take ownership of executing approved solutions from the stage of business case approval to Business Go-Live.

• Design and oversee startup plans, milestones, dependencies, risks, constraints, and mitigation strategies.

• Ensure that solution design, operational workflows, and validation activities meet the requirements of the study, program, and stakeholders.

• Verify readiness at each stage of startup and prior to Business Go-Live.

• Lead and coordinate efforts among Engineering, IT, Validation, QA, Regulatory, Data Management, Operations, Logistics, Vendors, Field Support, and Training.

• Convert solution concepts into requirements for devices, systems, services, and validation.

• Assist in managing vendor relationships, resolving issues, aligning designs, and collaborating on budgets.

• Provide troubleshooting support and engage with sites and customers to address complex challenges.

• Ensure that documentation, validation, training, support models, and escalation pathways are prepared.

• Collaborate with Solution Specialists on regulatory and compliance mandates.

• Lead initiatives for quality management, process enhancement, and continuous improvement.

• Contribute to the creation of SOPs, study templates, and materials for sites and patients.

• Manage issue resolution at the startup level and appropriately escalate risks related to scope, timelines, investments, or delivery.

• Communicate the status of startup activities, risks, and readiness to stakeholders, sponsors, and leadership.

• Transfer ownership to study execution leadership at Business Go-Live while maintaining solution-level escalation and support responsibilities.

⛳️ Requirements

• Proven experience in supporting respiratory clinical trials (e.g., asthma, COPD, pulmonary indications) is essential.

• In-depth knowledge of digital health, connected medical devices, and regulated clinical settings.

• Familiarity with FDA guidelines and global regulatory expectations and their effects on operations.

• Advanced project and program management proficiency in complex, matrixed organizations.

• Strong technical skills related to systems, platforms, integrations, and device workflows.

• Exceptional communication, stakeholder management, and executive-level presentation abilities.

• Demonstrated capability to build and sustain effective working relationships with internal teams, vendors, sponsors, sites, and clients.

• Bachelor’s degree or a relevant combination of education, training, and experience.

• Over 10 years of pertinent experience in healthcare, pharmaceuticals, life sciences, or digital health sectors.

• Proven leadership experience in managing personnel, operations, and cross-functional projects.

• Strong business acumen with experience in solution development, commercialization, and delivery.

• Candidates must currently reside in the EMEA region.

• Applications from candidates without direct respiratory trial experience explicitly demonstrated in their resume will not be accepted.

🏝️ Benefits

• Remote work opportunity.

• Occasional travel may be necessary.

• Chance to engage in innovative connected medical device and digital health solutions.

• A culture that promotes diversity, inclusion, and belonging.