Associate Director, Labeling & Technical Writer

Bdjobs

San Diego, CA, USA
Base: $169,800.00 - $280,300.00 usd annual; bonus/...
Fully remote
7+ years technical writing experience
5+ years regulated industry experience
3+ years people leadership experience
The role serves as a strategic documentation leader responsible for driving the development and quality of technical documentation for Class II medical devices

Job Summary

  • The role serves as a strategic documentation leader responsible for driving the development and quality of technical documentation for Class II medical devices.
  • Candidates must lead a high-performing team while collaborating across diverse business functions to ensure regulatory compliance with FDA and EU MDR standards.
  • BD offers a culture that values authentic contributions, continuous learning, and the opportunity to reinvent the future of health through transformative solutions.

Matching Summary

The role serves as a strategic documentation leader responsible for driving the development and quality of technical documentation for Class II medical devices.

Salary

Base: $169,800.00 - $280,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards

Skills & Requirements

Must-have

  • 7+ years technical writing experience
  • 5+ years regulated industry experience
  • 3+ years people leadership experience
  • FDA EU MDR ISO 13485 compliance knowledge
  • End-to-end documentation lifecycle management
  • Experience with IFU and labeling content

Nice-to-have

  • Master's degree in Technical Communication
  • Experience with global regulatory submissions
  • Familiarity with Agile methodologies
  • Strong initiative and problem-solving skills
  • Ability to work independently with minimal supervision

Key Requirements

  • Bachelor's degree in Technical Communication or Engineering
  • 7+ years in technical writing or documentation development
  • 5+ years within medical device or pharmaceutical industry
  • 3+ years of people leadership experience
  • Knowledge of engineering change control processes

Work Rights

Not specified

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