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Danaher Corporation Regulatory Affairs Associate in Shanghai, China

RESPONSIBILITIES

  • Works with project teams for New Product Development, Sustaining, and cost-saving projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project.

  • Assists in the preparation of regulatory submissions.

  • Identifies specific NMPA requirements, updates, and information as it relates to Devicor’s business.

  • Completes reviews of labeling content, product and process changes, and product documentation.

  • Maintains regulatory files in a format consistent with requirements.

  • Analyzes support data for claims verification.

  • Develops processes and checklists and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling promotional materials, and assuring the validity of regulatory compliance issues.

  • Collaborates and assists the Global Regulatory Team to support product compliance internationally.

  • Maintains the listing of relevant Chinese standards.

  • Identifies specific changes in global regulations, develops strategies for compliance, and provides updates of upcoming changes as appropriate.

  • Provides regulatory support for internal and external (Regulatory Agency) audits and assists with resolving observations.

  • Evaluates and implements procedures pertaining to corporate and departmental regulatory activities.

  • Other duties as assigned.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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