Global Medical Device Regulatory & Compliance Lead

Jabil; Albuquerque (NM); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Competitive base salary

Medical, Dental, Vision Insurance

401K match

Employee Stock Purchase Plan

Paid Time Off

Tuition Reimbursement

Commuter Benefits

Employee Assistance Program

Pet Insurance

Adoption Assistance

Annual Merit Increases

Job summary

Jabil seeks a Regulatory Affairs & Compliance Manager to lead strategies ensuring FDA and ISO 13485 compliance across manufacturing operations. You will coordinate regulatory submissions, guide design changes, and partner with Quality, Operations, and Engineering to drive a culture of compliance.

You will act as primary regulatory liaison during FDA inspections and external audits, delivering training and mentoring to teams while supporting process improvements and digital quality initiatives.

Qualifications

• Bachelor's degree in a technical field; Master’s preferred.
• Minimum 3 years of Regulatory Affairs experience in medical devices.
• Minimum 6 years of Quality Assurance/Quality Systems experience in medical devices.
• Minimum 3 years of leading audits (ISO 13485) or regulatory inspections.

Responsibilities

• Develop regulatory strategies to support product lifecycle for a CMO.
• Ensure compliance with FDA, ISO 13485, and international regulations.
• Lead regulatory inspections and customer/regulatory audits; respond to findings.

Skills

Regulatory affairs

Quality management

Regulatory writing

Cross-functional leadership

Project management

Communication

Education

Bachelor's degree in a technical field

Master's degree preferred

Tools

eQMS

Document management

MS Office

Job description

Jabil seeks a Regulatory Affairs & Compliance Manager to lead strategies ensuring FDA and ISO 13485 compliance across manufacturing operations. You will coordinate regulatory submissions, guide design changes, and partner with Quality, Operations, and Engineering to drive a culture of compliance.

You will act as primary regulatory liaison during FDA inspections and external audits, delivering training and mentoring to teams while supporting process improvements and digital quality initiatives.