Global Regulatory Packaging Compliance Leader

GE HealthCare

Bengaluru

On-site

INR 2,500,000 - 5,000,000

Full time

13 days ago

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Job summary

GE HealthCare seeks a Global Regulatory Packaging Compliance Leader to establish and drive worldwide packaging regulatory strategies across business segments and markets. You will monitor regulations such as PPWR, assess impacts, and translate complex rules into actionable plans for engineering, quality, sourcing, and manufacturing.

You will partner with Regulatory Affairs, Product Compliance, Engineering, Packaging COE, and leadership teams to ensure regulatory readiness, governance, and timely

Qualifications

  • Bachelor's degree in Mechanical Engineering, Regulatory Affairs, Environmental Science, or related technical field.
  • 15+ years of professional experience in Regulatory Affairs, Regulatory Compliance, or a related regulated industry function.
  • Experience in packaging regulatory affairs within medical devices or healthcare manufacturing.

Responsibilities

  • Establish and lead global packaging regulatory compliance frameworks across segments and markets.
  • Monitor and assess global packaging regulations; translate into actionable requirements.
  • Develop governance, readiness assessments, and implementation roadmaps.
  • Coordinate regulatory assessments and cross-functional initiatives with global teams.
  • Maintain regulatory declarations, documentation, and risk registers.
  • Provide leadership updates on regulatory developments and compliance status.

Skills

Regulatory leadership
Cross-functional collaboration
Regulatory compliance strategy
Regulatory risk management

Education

Bachelor's degree in Mechanical Engineering
Bachelor's degree in Regulatory Affairs
Bachelor's degree in Environmental Science

Job description

Job Description Summary

The Global Regulatory Packaging Compliance Leader will be responsible for establishing and leading global packaging regulatory compliance across GE HealthCare business segments, product lines, and markets. This strategic role will proactively monitor existing and emerging packaging regulations, assess regulatory applicability and business impact, and translate complex regulatory requirements into actionable compliance strategies, technical requirements, and implementation plans.

As the global focal point for packaging regulatory compliance, the role will drive regulatory readiness, develop compliance governance frameworks, and provide early visibility into regulatory changes that could impact GE HealthCare products, packaging, manufacturing operations, and market access. The position will work closely with Regulatory Affairs, Product Compliance, Engineering, Packaging, Quality, Sourcing, Manufacturing, Sustainability, EHS, Logistics, and global leadership teams to ensure timely and effective regulatory implementation.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description
Roles and Responsibilities
  • Lead and establish a global packaging regulatory compliance framework across GE HealthCare business segments, products, and geographic markets.
  • Monitor existing and emerging global packaging regulations, including the European Union Packaging and Packaging Waste Regulation (PPWR), Extended Producer Responsibility (EPR), and applicable country-specific packaging, environmental, recycling, and waste management requirements.
  • Conduct regulatory applicability assessments, evaluate business and operational impacts, and proactively communicate regulatory changes, compliance risks, and implementation priorities to relevant stakeholders and leadership.
  • Interpret complex regulatory requirements and translate them into actionable technical, engineering, packaging, quality, sourcing, and business requirements.
  • Develop and drive regulatory implementation roadmaps, compliance calendars, readiness assessments, and cross-functional action plans to support timely compliance.
  • Lead and coordinate PPWR regulatory assessments, technical compliance activities, and implementation initiatives in collaboration with relevant global teams.
  • Establish and maintain standardized regulatory compliance processes, procedures, governance mechanisms, and documentation requirements.
  • Coordinate the preparation and maintenance of regulatory declarations, technical documentation, compliance assessments, change notifications, and supporting evidence.
  • Develop and maintain a global packaging regulatory risk register, identify compliance gaps, and coordinate risk mitigation and corrective action plans.
  • Establish regulatory compliance KPIs, dashboards, and monitoring mechanisms to track regulatory readiness, implementation progress, and compliance risks.
  • Coordinate EPR-related compliance activities, including country-specific registration, reporting, documentation, and clarification of functional ownership and accountability.
  • Partner with Regulatory Affairs, Product Compliance, Engineering, Packaging COE, Quality, Sourcing, Manufacturing, Sustainability, EHS, Logistics, and suppliers to drive consistent regulatory compliance practices globally.
  • Develop and deliver regulatory training, compliance communications, and awareness programs to strengthen organizational understanding of packaging regulatory obligations.
  • Provide regular updates and recommendations to global leadership on regulatory developments, business risks, compliance status, and implementation progress.
  • Drive continuous improvement and standardization of packaging regulatory compliance practices while supporting uninterrupted business operations and global market access.
Required Qualifications
  • Bachelor's degree in Mechanical Engineering, Regulatory Affairs, Environmental Science, or a related technical discipline.
  • Minimum 15 years or more of professional experience in Regulatory Affairs, Regulatory Compliance, Product Compliance, or a related regulated industry function.
  • Experience in Packaging Regulatory Affairs or Regulatory Compliance within the medical device, MedTech, healthcare technology, or other highly regulated manufacturing industries.
  • Strong experience interpreting, assessing, and implementing regulatory requirements across multiple countries or geographic regions.
  • Demonstrated ability to translate complex regulatory requirements into practical business processes, technical requirements, and implementation plans.
  • Experience leading regulatory compliance initiatives and coordinating activities across global, cross-functional teams.
  • Strong understanding of regulatory risk ass
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