Regulatory Compliance Specialist

hace 3 días

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

About Johnson & Johnson:

We are the world's largest healthcare company, transforming lives through innovation and pioneering spirit.

Our commitment to diversity and inclusion is a cornerstone of our success, welcoming talented individuals from all backgrounds to join our team.

About the Role:

As a Regulatory Compliance Specialist in Ciudad Juarez, Mexico, you will lead the Source Quality Management process, ensuring suppliers meet Biosense Webster's and J&J's policies, global regulations, and industry standards.

Responsibilities:

  • Serve as management oversight for direct reports, focusing on Purchasing Controls/Supplier Quality Management for assigned supplier categories globally
  • Develop and deploy strategies to effectively manage direct and indirect Suppliers with appropriate risk-based controls
  • Collaborate with Procurement on process/product improvement projects and implement Purchasing Controls
  • Analyze quality data and identify trends impacting risks/benefits requirements of process, product, and quality systems with primary responsibility for the development and maintenance of BWI external suppliers
  • Utilize key knowledge of business processes, analytical tools, and the regulatory environment to support the supplier quality management lifecycle
  • Prepare Supplier Quality Agreements at the direction of the Director/Senior Manager
  • Lead/assist in the maintenance of the supplier quality relationship (proactive quality reviews, risk-sensing modeling, follow-up on corrective actions, metrics development/improvements, etc.)
  • Understand or anticipate the customer's needs and add value by providing specific metric information tailored to the particular business environment
  • Proactively identify unmet business needs and take actions to identify internal/external customer requirements and translate them into actions with appropriate prioritization and organizational communication
  • Respond proactively to emerging industry, regulatory, and business changes
  • Compile and recommend data-driven conclusions for Management Review
  • Leads/participates in the external supply selection process to provide quality system expertise
  • Analyzes quality system trends, identifies issues, and implements appropriate actions
  • Participates in franchise-wide assessments and applies risk mitigation strategies to address the regulatory gaps identified in the quality systems for external supply
  • Participates in benchmarking and voice of the customer activities and applies learning's to the external supply quality systems enhancement projects
  • Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, Medical Device Directive (MDD), and EU MDR requirements)
  • Interfaces with site Supplier Quality Management Leads to deploy tactical responses
  • Responsible for communicating business-related issues or opportunities to next management level
  • 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
  • Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

Requirements:

A minimum 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.

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