Global Regulatory Affairs & Compliance Leader

JABIL CIRCUIT, INC; Los Lunas (NM); On-site; USD 120,000 - 150,000; Full time

Job summary

Jabil Circuit, Inc. is seeking a Regulatory Affairs & Compliance Manager to lead regulatory affairs and quality system compliance across manufacturing operations.

You will liaise with regulatory authorities, drive inspections readiness, and coordinate audits to maintain global regulatory compliance throughout product lifecycles. The role requires extensive experience in regulatory affairs within the medical device industry, quality systems, and leadership, including strategic development and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline.
• Master's degree preferred.
• Minimum 3 years of experience in Regulatory Affairs within the medical device industry.
• Minimum 6 years of experience in Quality Assurance, Quality Systems or Compliance within the medical device industry.
• Minimum of 3 years of experience conducting audits in the medical device industry (ISO 13485, Lead Auditor certification preferred).
• Minimum 3 years of leadership or management experience.
• Experience supporting Health Authorities inspections and/or external audits.

Responsibilities

• Develop, implement, and maintain regulatory affairs and quality system compliance programs.
• Lead regulatory strategies and ensure global regulatory compliance.
• Coordinate FDA inspections, certification audits, and regulatory observations responses.
• Partner with cross-functional teams to ensure lifecycle compliance.
• Mentor regulatory training across the organization.
• Promote culture of compliance and continuous improvement.
• Support harmonization of regulatory and quality processes.

Skills

Regulatory affairs

Quality Systems

Lead Auditor

Internal Audits

Regulatory Writing

CAPA

Project management

Cross-functional leadership

eQMS

Risk Management

Education

Bachelor's in Engineering

Master's degree preferred

Tools

eQMS software

Job description

Jabil Circuit, Inc. is seeking a Regulatory Affairs & Compliance Manager to lead regulatory affairs and quality system compliance across manufacturing operations.

You will liaise with regulatory authorities, drive inspections readiness, and coordinate audits to maintain global regulatory compliance throughout product lifecycles. The role requires extensive experience in regulatory affairs within the medical device industry, quality systems, and leadership, including strategic development and