This strategic role leads the development and quality evolution of technical documentation for Class II medical devices while managing a high-performing team
Job Summary
This strategic role leads the development and quality evolution of technical documentation for Class II medical devices while managing a high-performing team.
The position requires deep expertise in regulatory compliance including FDA, EU MDR, and ISO 13485 standards to ensure all documentation meets global requirements.
Candidates will collaborate across engineering, quality, and marketing functions to drive process improvements and maintain operational excellence in a fast-paced environment.
Matching Summary
This strategic role leads the development and quality evolution of technical documentation for Class II medical devices while managing a high-performing team.
Salary
Base: $169,800.00 - $280,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development programs
Skills & Requirements
Must-have
7+ years technical writing experience
5+ years regulated industry experience
3+ years people leadership experience
FDA and EU MDR regulatory compliance knowledge
ISO 13485 standards expertise
Experience with Class II medical devices
Nice-to-have
Master's degree in Technical Communication
Experience with global regulatory submissions
Familiarity with Agile methodologies
Knowledge of electro-mechanical systems
Strong cross-functional collaboration skills
Key Requirements
Bachelor's degree in Technical Communication or Engineering
7+ years in technical writing or documentation
5+ years in medical device or pharma industry
3+ years of direct people management experience
Proficiency with DTP tools like MadCap Flare or Adobe FrameMaker