Qe 4 - Quality Regulatory Requirements

Johnson & Johnson MedTech

Jacksonville, Florida, United States of America
Base: $94,000.00 - $151,800.00; bonus/equity: not ...
External regulatory requirements management
Quality management system
Us fda 21 cfr part 820
Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and assesses new/revised J&J quality standards

Job Summary

  • Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and assesses new/revised J&J quality standards.
  • Collaborates with various functional areas and subject matter experts to ensure alignment with external, global regulatory, and internal J&J quality standards.
  • Supports quality system initiatives, audits, investigations, nonconformances, and corrective actions to improve the quality system.

Matching Summary

Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and assesses new/revised J&J quality standards.

Salary

Base: $94,000.00 - $151,800.00; Bonus/Equity: Not specified; Benefits: Eligible for consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, vacation, sick time, holiday pay, work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, military spouse time-off.

Skills & Requirements

Must-have

  • External Regulatory Requirements Management
  • Quality Management System
  • US FDA 21 CFR Part 820
  • ISO13485 requirements
  • Document Management System
  • Change Control
  • Nonconformance and CAPA

Nice-to-have

  • Supportive of innovation
  • Customer-focused improvements
  • Collaborating with SMEs
  • Methodical time management
  • Flexibility for multiple assignments

Key Requirements

  • Knowledge of quality system requirements
  • Familiarity with US FDA 21 CFR Part 820
  • Familiarity with ISO13485 requirements
  • Ability to work independently and collaboratively
  • Manage time, assignments, projects and tasks methodically

Work Rights

Not specified

Tailored Resume

Cover Letter