Global Regulatory & Quality Compliance Leader

JABIL CIRCUIT, INC

Rio Rancho (NM)

On-site

USD 120,000 - 180,000

Full time

6 days ago
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Job summary

JABIL CIRCUIT, INC. is seeking a Regulatory Affairs & Compliance Manager to develop, implement, and maintain regulatory affairs and quality system programs ensuring global regulatory compliance for manufacturing operations.

You will lead regulatory activities, support inspections, and partner with cross-functional teams to maintain product lifecycle compliance. The role requires liaising with authorities, guiding product introductions, changes, and transfers, and leading CAPA and internal audits

Qualifications

  • Minimum 3 years of Regulatory Affairs experience in the medical device industry.
  • Minimum 6 years of Quality Assurance, Quality Systems or Compliance in the medical device industry.
  • Minimum 3 years of leadership or management experience.
  • Experience supporting Health Authorities inspections and/or external audits.
  • Bachelor's degree in a related technical discipline; Master's preferred.

Responsibilities

  • Develop regulatory strategies and ensure global regulatory compliance for manufacturing operations.
  • Lead regulatory activities and coordinate interactions with regulatory authorities and certification bodies.
  • Support regulatory inspections and external audits; prepare responses to observations.
  • Guide product introductions, design changes, transfers, and process updates; review regulatory docs.
  • Maintain establishment registrations and compliance metrics; drive CAPA and internal audits.

Skills

Regulatory leadership
Regulatory writing
Audits (ISO13485)
Quality management
Cross-functional collaboration
eQMS
MS Office

Education

Bachelor's degree in Engineering/Life Sciences/Regulatory Affairs/Quality
Master's degree preferred

Tools

eQMS software
Document management systems

Job description

JABIL CIRCUIT, INC. is seeking a Regulatory Affairs & Compliance Manager to develop, implement, and maintain regulatory affairs and quality system programs ensuring global regulatory compliance for manufacturing operations.

You will lead regulatory activities, support inspections, and partner with cross-functional teams to maintain product lifecycle compliance. The role requires liaising with authorities, guiding product introductions, changes, and transfers, and leading CAPA and internal audits

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