Job Summary

• 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

Key Responsibilities

1. Support quality strategy, annual plans, and ensure CMMI/ISO certification alignment for sustained maturity.
2. Ensure consistent and predictable delivery quality across verticals through capability building and project evaluation.
3. Deploy standardized delivery processes and drive continuous improvement through knowledge reuse and best practices.
4. Enhance quality operations by improving consistency, efficiency, and leveraging economies of scale.
5. Foster a high-maturity quality culture in an industrialized delivery environment.

Skill Requirements

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Other Requirements

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