Global Medical Device Regulatory Affairs Leader

JABIL CIRCUIT, INC; Los Lunas (NM); On-site; USD 120,000 - 170,000; Full time

Job summary

JABIL CIRCUIT, INC is seeking a Regulatory Affairs & Compliance Manager to lead regulatory strategy and quality system compliance across manufacturing operations. You will coordinate with cross-functional teams to ensure products stay compliant through their lifecycle and serve as a primary liaison during FDA inspections and audits.

The role emphasizes development of regulatory programs, global registrations, and readiness for inspections, with a focus on continuous improvement and strong

Qualifications

• 3+ years Regulatory Affairs in the medical device industry.
• 6+ years Quality Assurance or Quality Systems in the medical device industry.
• 3+ years conducting audits (ISO 13485; Lead Auditor preferred).
• Regulatory writing and technical documentation experience.
• Ability to influence cross-functional teams without direct authority.

Responsibilities

• Develop and execute regulatory strategies to support lifecycle management.
• Ensure compliance with FDA, ISO 13485, ANVISA, PMDA, and global requirements.
• Maintain establishment registrations globally and respond to regulatory requests.
• Provide regulatory guidance for new product introductions and changes.
• Lead or support inspections and audits by FDA and certification bodies.
• Collaborate with Quality, Operations, Engineering and Supply Chain.

Skills

Regulatory strategy

FDA compliance

QMS (ISO 13485)

Cross-functional leadership

Regulatory writing

Audit leadership

eQMS experience

Education

Bachelor's degree in Engineering or Life Sciences, Regulatory Affairs, Quality, or related

Master's degree preferred

Tools

eQMS

Document management systems

Microsoft Office

Job description

JABIL CIRCUIT, INC is seeking a Regulatory Affairs & Compliance Manager to lead regulatory strategy and quality system compliance across manufacturing operations. You will coordinate with cross-functional teams to ensure products stay compliant through their lifecycle and serve as a primary liaison during FDA inspections and audits.

The role emphasizes development of regulatory programs, global registrations, and readiness for inspections, with a focus on continuous improvement and strong