Qe 4 - Quality Regulatory Requirements

Johnson & Johnson UK

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 JJVC's process to assess new/revised J&J quality standards

Job Summary

  • Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and JJVC's process to assess new/revised J&J quality standards.
  • Collaborates with various functional areas, partners with subject matter experts (SMEs) and regional regulatory affairs, to ensure alignment with new/revised external standards, global regulatory requirements, and internal J&J quality standards.
  • Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, and various time off benefits including vacation, sick time, and holidays.

Matching Summary

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

Salary

Base: $94,000.00 - $151,800.00; Bonus/Equity: Not specified; Benefits: Eligible for Company's 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
  • CAPA

Nice-to-have

  • Agility Jumps
  • Analytical Reasoning
  • Analytics Dashboards
  • Coaching
  • Collaborating
  • Data Compilation
  • Data Quality
  • Data Savvy
  • Problem Solving
  • Quality Services
  • System Audits
  • Systems Analysis

Key Requirements

  • Knowledge of quality system requirements
  • Familiarity with US FDA 21 CFR Part 820
  • Familiarity with ISO13485 requirements
  • Ability to work independently and/or collaboratively
  • Manage time, assignments, projects and tasks
  • Flexibility to support and manage multiple assignments

Work Rights

Not specified

Tailored Resume

Cover Letter