Associate Director, Global Process Owner - Field Actions

About This Role

This Associate Director serves as the global process owner for Field Actions, overseeing the design, maintenance, and continuous improvement of the process to ensure alignment with global regulatory requirements and BD quality system expectations. The role drives process clarity, harmonization, and data-driven improvements across the organization.

Responsibilities

• Own and manage the comprehensive global Field Action process, including design, maintenance, and revision control
• Ensure alignment with critical regulations (21 CFR Parts 7, 806, 820, ISO 13485, and regional requirements)
• Develop and maintain global procedures, work instructions, forms, and job aids
• Define and sustain clear governance expectations, roles, and responsibilities across all stakeholder groups
• Serve as process expert during audits, inspections, and regulatory inquiries
• Provide authoritative guidance to Business Units and Regions on process interpretation
• Create and maintain comprehensive global training materials for the Field Action process
• Develop and track meaningful process metrics to monitor performance, timeliness, completeness, and compliance
• Lead process improvement initiatives that enhance clarity, efficiency, and compliance
• Collaborate across functions (Business Unit Quality, Regional Quality, Regulatory Compliance, Medical Affairs, Legal) to maintain global alignment

Requirements

• Bachelor’s degree in life Sciences, engineering, or a related field
• 8 years of experience in regulated industries such as medical devices, diagnostics, or pharmaceuticals
• Experience in field actions, quality systems, regulatory compliance, post market quality, or closely related areas
• Working knowledge of global regulatory requirements for field actions such as 21 CFR Parts 7, 806, and 820 and ISO 13485
• Experience working in global, matrixed environments
• Proven change agent with ability to drive improvements across large organizations
• Strong knowledge of quality systems in medical devices, diagnostics, or pharmaceuticals
• Ability to interpret regulatory requirements and translate them into clear process expectations
• Strong communication, facilitation, and cross-functional collaboration skills
• Ability to lead process improvements and use data to identify trends or improvement opportunities
• Ability to work independently and manage multiple priorities

Qualifications

• Bachelor’s degree in life Sciences, engineering, or a related field
• 8 years of experience in regulated industries such as medical devices, diagnostics, or pharmaceuticals. Experience in field actions, quality systems, regulatory compliance, post market quality, or closely related areas.

Nice to Have

• MS or MBA
• Experience maintaining or designing global quality processes
• Familiarity with post market regulatory expectations in the United States and key global regions

Skills

* Required skills

Benefits