Global Regulatory Affairs and Compliance Manager

About the role

As the Global Regulatory Affairs and Compliance Manager, you will lead assigned Quality System processes, including internal audits, customer audits, ISO Registration audits, and FDA Inspections. You will prepare submissions and responses to FDA and ISO Registrars when required. This role serves as the primary contact for site departments, business units, and corporate functions, providing guidance and development opportunities to direct reports.

Responsibilities

• Champion and serve as the subject matter expert for Quality Systems and Compliance programs.
• Ensure the site’s quality system development, maintenance, and compliance with business unit requirements, medical device regulations, and standards (e.g., U.S. – FDA, ISO 13485, ISO 9001).
• Lead department activities within the Quality Systems function, including:
  • Document and Data Control
  • Retain and Records Retention
  • Training
  • Corrective and Preventive Action
  • Change Control
  • Deviation
  • Supplier Audits
  • Supplier Corrective Action Requests
  • Electronic System Development/Validation
  • Management Review
  • Risk Management
  • Auditing
  • Agency Inspections
  • Quality Improvement Initiatives
• Maintain the accuracy of the regulatory contact and submission log; provide regulatory guidance to internal project teams.
• Lead follow-up, negotiation, and resolution of issues regarding current and future submissions with regulatory agencies and ISO registrars.
• Develop and enhance regulatory knowledge at local and national levels to support surveillance activities.
• Support currently marketed products, including reviewing engineering changes, labeling, promotional material, product changes, and documentation requiring government approval.
• Propose and execute Quality System improvement opportunities and develop Business Continuity Planning programs.
• Write, review, and approve validations in accordance with customer and regulatory requirements.
• Establish, maintain, and report Quality System metrics to local teams, management, and global business units.
• Ensure timely and comprehensive closure of systems, adhering to all in-process milestones.
• Facilitate prioritization and resource discussions with stakeholders.
• Support the effectiveness of Quality Systems and Compliance programs through collaboration with stakeholders.
• Manage expenses, support budget planning, scheduling, and site-wide process improvement opportunities.
• Perform all duties in alignment with Jabil’s Corporate Code of Ethics, policies, employment laws, health regulations, and safety requirements.
• Other duties as assigned.

Requirements

• Knowledge of U.S. and international medical device quality system regulations, standards, and best practices (21 CFR 820, ISO 13485).
• Experience with compliance assessments, gap assessments, and risk management assessments.
• Experience with program change management practices, lean or six sigma, and program/system integration efforts.
• Strong computer skills (Word, Excel, PowerPoint).
• Strong interpersonal, leadership, collaboration, and relationship-building skills.
• Ability to work in a team environment, influence change, and handle ambiguity.

Qualifications

• Bachelor’s degree required (Quality, Regulatory, Engineering, Business, or Life Sciences).
• Master’s degree desired (Quality, Regulatory).
• 6+ years of industry experience within Quality and/or Regulatory, including managing high-performing teams.
• American Society of Quality, Certified Quality Auditor (CQA) credentials required.
• Regulatory Affairs Professional Society (RAPS) Certification desired.
• Or a combination of education, experience, and/or training.