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JOB DESCRIPTION

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Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access!

• Develops and updates local, regional, and global regulatory strategies based on regulatory intelligence and emerging changes.
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Identifies regulatory obstacles, anticipates emerging issues, and proposes solutions or refinements based on regulatory outcomes
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Evaluates product classification and determines regulatory submission requirements, approval pathways, and compliance options at local, national, and international levels, preparing and submitting both electronic and paper regulatory filings in line with applicable guidelines.
• Provides regulatory guidance and technical input throughout the product lifecycle, ensuring compliance with global regulatory requirements.
• Develops and implements new regulatory procedures and SOPs and provides training to stakeholders to ensure compliance across the organization.
• Assesses the acceptability of quality, preclinical, and clinical documents for submission and ensures compliance with regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes for changes that do not require submissions
• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
• Engages and negotiates with regulatory authorities throughout the product lifecycle, ensuring effective communication, monitoring submission progress, and submitting applicable reports or notifications during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labeling
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims