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Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Lead and govern the global UDI program
- Ensure compliance with FDA, EU MDR, and other applicable international UDI regulations
- Govern functional data owners connected to UDI Health Authority records
- Own UDI-related processes, procedures, and controls in alignment with quality and regulatory standards
- Partner with technology and digital teams to establish and maintain UDI process capabilities
- Lead collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams
- Support regulatory inspections, internal audits, and health authority interactions related to UDI compliance
- Monitor global regulatory trends and translate evolving requirements into scalable business and quality management system processes
- Drive continuous improvement to enhance UDI data utilization, efficiency, and compliance sustainability
- Own periodic reviews demonstrating effective processes and execution
- Provide coaching and leadership to team members and stakeholders
Requirements
What you’ll need- Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field
- 6–8 years of proven experience in Quality Assurance, Regulatory Compliance, or process engineering within a regulated industry
- Medical device experience strongly preferred
- Proven experience with UDI regulations and global regulatory frameworks, including FDA and EU MDR
- Solid understanding of quality systems, data governance, and computerized system validation
- Proven ability to lead cross-functional, global initiatives in a matrixed organization
- Experience supporting audits and/or regulatory inspections
- Strong analytical, problem-solving, and risk-based decision-making skills
- Excellent written and verbal communication skills
- English language capability; additional languages a plus
- Up to 15% domestic and international travel
- Preferred: enterprise systems supporting UDI and product data, such as ERP, PLM, and labeling systems
- Preferred: prior people-leadership or matrix leadership experience
- Preferred: experience within complex medical device portfolios
- Preferred: familiarity with new product introduction, global supply chain, and labeling processes
- Preferred: change management or continuous improvement experience in regulated environments
- ASQ, RAC, or equivalent quality/regulatory certifications preferred
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Eligibility for the Company’s long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and disability accommodations