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Senior QA LeadHcltech • United States
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Senior QA Lead

Hcltech
  • US
    United States
  • US
    United States
Postuler Maintenant

À propos

Senior QA Lead
Provide regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for modified product launches in the global market. Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to Change Notifications, Technical Documents, and correspondence with Notified Bodies. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Define data and information needed for regulatory approvals. Develop labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Provide Regulatory Affairs support during internal and external audits. Plan schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion. Assist in the development of improved and efficient processes practices for Regulatory Affairs processes. Represent Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues, including Purchased for Resale products. Partner with other functions to define and generate data to assist with regulatory submissions. Review and provide regulatory authorization for various changes to product, procedures, etc. Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates. Support quality strategy, annual plans, and ensure CMMI/ISO certification alignment for sustained maturity. Ensure consistent and predictable delivery quality across verticals through capability building and project evaluation. Deploy standardized delivery processes and drive continuous improvement through knowledge reuse and best practices. Enhance quality operations by improving consistency, efficiency, and leveraging economies of scale. Foster a high-maturity quality culture in an industrialized delivery environment. Why HCLTech?
At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first. HCLTech is a global technology company, home to more than 226,300 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending December 2025 totaled $14.5 billion. Compensation and Benefits
A candidate's pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.
  • United States

Compétences linguistiques

  • English
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