Want (Remote) Principal Regulatory Affairs Specialist, Software in USA

Job title: (Remote) Principal Regulatory Affairs Specialist, Software Company: Stryker Job description: Work Flexibility: Remote or Hybrid or Onsite Stryker is one of the world s leading medical technology companies and together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at We are currently seeking a Principal Regulatory Affairs Specialist to join our Digital Robotics & Engineering (DRE) team, this position is Remote or Hybrid in the USA. Preference to Eastern and Central states to align with global partners. Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do This position will work in close collaboration with the Digital Robotics & Engineering (DREs) Commercial Division partners to provide knowledge and guidance to new product development teams. Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures focused in the areas of DREs digital portfolio. This includes but is not limited to Clinical Decision Support Software, Extended Reality (XR), and Artificial Intelligence / Machine Learning (AI/ML), and cloud and other connected devices and platforms.

• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
• Participates in advocacy activities of a more advanced strategic nature.
• Develops and updates global, regional, and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies in collaboration with Commercial Division RA.
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy.
• Identifies and consults on regulatory pathways for initial product designs and provides input to internal stakeholders.
• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles.
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy).
• Partners with Commercial Divisions in negotiating with regulatory authorities on complex issues throughout the product lifecycle.
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
• Identifies the need for and collaborates with Commercial Division RA teams to manage the development and execution of new regulatory procedures and standard operating procedures focused in the areas of Digital SW products and AI.
• Develops and manages programs that train stakeholders on current and new regulatory requirements focused in the areas of Digital SW products and AI.to ensure enterprise-wide compliance.
• Provides strategic in

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