Job Overview:
Pay Range: $62.16/hr - $67.16/hr
Requirement/Must Have:
- Bachelor’s Degree, or equivalent experience.
- 2+ years of medical device labeling experience.
- Knowledge of domestic and international medical device regulatory requirements for product labeling and unique device identification (e.g. 21 CFR 801 and EU MDR).
- Knowledge of quality management system requirements such as design change control, document control, requirements, and regulatory approvals.
- Strong verbal and written communication skills.
- Excellent interpersonal skills working across multiple divisions.
- Attention to detail, well organized and time efficient.
- Ability to multi-task and work independently.
- Technical writing skills.
Responsibilities:
- Leads the Instructions for Use (IFU) creation and ensures compliance to global regulatory requirements, completes labeling reviews to verify compliance of labeling, and implements IFU with cross functional teams.
- Manages marketing claims.
- Coordinates internal marketing and post-market material review/approval.
- Establishes systems for physical labeling controls.
- Maintains labeling in accordance to global standards and regulatory requirements.
- Provides up-to-date guidance and implementation of evolving global labeling requirements.
- Coordinates with Regulatory Affairs to incorporate country-specific requirements and translations for international markets.
- Participates in design and change control processes to update labeling related to new product developments, product changes, or regulatory updates.
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting powerhouse. Proudly recognized as a nationally and locally certified diversity firm, Cynet delivers agile, scalable talent solutions across industries. With an active footprint in all 50 U.S. states and Canada, we support thousands of consultants through our expansive, high-performing recruitment engine operating across North America and Asia—ensuring speed, quality, and consistency in every hire.