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Regulatory Compliance Manager

hace 1 mes

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

Johnson & Johnson Medical Devices Companies is a leader in transforming the delivery of healthcare and helping people live longer, healthier lives.

We are seeking an experienced Regulatory Compliance Manager to join our team in Ciudad Juarez, Mexico.

Estimated Annual Salary: $120,000 - $180,000

About the Role:

This role leads/manages the Source Quality Management (SQM)/Purchasing Control process and ensures that Biosense Webster Suppliers provide purchased finished goods, direct and indirect materials or services in compliance with BWI and J&J policies/procedures, Global Regulations and industry standards.

Main Responsibilities:

  1. Serves as management oversight for direct reports focusing on Purchasing Controls/Supplier Quality Management for assigned supplier categories globally;
  2. Develops and deploys strategies to effectively manage direct and indirect Suppliers with appropriate risk-based controls;
  3. Collaborates with Procurement on process/product improvement projects and in the implementation of Purchasing Controls;
  4. Analyzes quality data and identifies trends impacting risks/benefits requirements of process, product and quality systems with primary responsibility for the development and maintenance of BWI external suppliers;
  5. Utilizes key knowledge of business processes, analytical tools, and the regulatory environment to support the supplier quality management lifecycle;
  6. Prepares Supplier Quality Agreements at the direction of the Director/Senior Manager;
  7. Leads/assists in the maintenance of the supplier quality relationship (proactive quality reviews, risk-sensing modeling, follow-up on corrective actions, metrics development/improvements, etc.);
  8. Understands or anticipates the customer's needs and adds value by providing specific metric information tailored to the particular business environment;
  9. Proactively identifies unmet business needs and takes actions to identify internal/ external customer requirements and translates them into actions with appropriate prioritization and organizational communication;
  10. Responds proactively to emerging industry, regulatory, and business changes;
  11. Compiles and recommends data driven conclusions for Management Review;
  12. Leads/participates in the external supply selection process to provide quality system expertise;
  13. Analyzes quality system trends, identifies issues, and implements appropriate actions;
  14. Participates in franchise-wide assessments and applies risk mitigation strategies to address the regulatory gaps identified in the quality systems for external supply;
  15. Participates in benchmarking and voice of the customer activities and applies learning's to the external supply quality systems enhancement projects;
  16. Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, Medical Device Directive (MDD), and EU MDR requirements);
  17. Interfaces with site Supplier Quality Management Leads to deploy tactical responses;
  18. Responsible for communicating business related issues or opportunities to next management level;
  19. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable;
  20. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
  21. Performs other duties assigned as needed.

Requirements:

  • A minimum a BA/BS degree in Engineering or Life Science is required;
  • A minimum of 6 years of experience in a regulated industry is required;
  • Supplier Quality or Procurement experience is preferred;
  • People management/talent development experience desirable;
  • Hands on strategy development and deployment experience is preferred;
  • General Understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards).