Shire Lead, Connected & Software Devices - Lexington, MA in Lexington, Massachusetts
Connected and Software Device Lead is responsible for managing the delivery of new Software as Medical Devices (SaMD) product launches, upgrades to existing products, and the resolution of post-market surveillance issues. The primary focus will be on commercial device portfolio including devices that are currently in market such as Patient eDiary Mobile Devices. This is a global role and includes supporting multiple Class I devices. The role requires leadership interaction across multiple different functions (e.g., regulatory, quality, medical affairs, commercial, research and development, technology teams, etc.) and high level engagement across different technical vendors. This role will contribute to the development of business cases. This role requires software device control and information technology expertise and a strong understanding of commercial go-to market launch strategies and emerging software as medical device changing regulations (globally). This role will need to specifically assess the intended use of mobile assets and determine if medical device classification is required (versus commercial mobile asset). The role will play key role in designing the controls associated with the proliferation of mobile tools through controlled inventories and processes (in partnership with pertinent cross-functional teams). This role will contribute to the thought leadership in strategies across connected health platforms and Software Medical Device (e.g., test and risk assessments strategies, and hardware and software integration, platform and app development vision, etc.). This role requires software device control and information technology expertise and a strong understanding of commercial go-to market launch strategies. This role requires strong communication skills and the ability to take complex or ambiguous ideas and synthesize into clear and concise action. This role performs a key role in SaMD audit / inspections and requires adherence to Shire’s compliance policies and procedures.
Education and Experience Requirements
8+ years of technical and functional experience in the healthcare industry
Demonstrated project results in commercial and / or digital technical delivery
Direct experience in SaMD environment and / or regulated validated system development
Demonstrated financial discipline in estimating technical efforts and managing budgets of $1M+ Experience in technical implementations required
Management experience in supervising 5+ resources
Strong communication skills and ability to articulate complex scenarios
Technical application development skills a plus
Experience in connected health technologies a plus (e.g., software device, electronic health records, portals, etc.).
Key Skills, Abilities, and Competencies
Experience with appropriate global regulations and standards - ISO 60601, Design Control - CFR 820.30, ISO 62304, ISO13485, ISO 14971, etc.
Able to scope and define device inputs for new device platforms.
Ability to work teams to develop new device assets.
Able to manage vendor teams.
Able to work in validated device environment with focus on compliance.
Able to work collaboratively.
Good written and oral communication skills.
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