Regulatory Affairs Labeling Manager
Primary Function
AVITA Medical Subject Matter Expert for product Labeling including Instructions for Use (IFU), primary and secondary product labels, advertising and promotional material.
Duties/Responsibilities
- Regulatory review and approval of labels, labeling, advertising and promotional materials
- Establish and manage documented procedures for creation and management of IFUs, procedure guides, and product labels
- Define Labeling format and content in compliance with US and international regulatory requirements
- Provide labeling guidance and input to Product Development, Global Operations, and Commercial teams
- Maintain UDI compliance
- Work together with Regulatory Associate to manage FDA submission of promotional materials (FDA Form 2253) and GUDID submissions
Special Knowledge/Skill
- Review and approval of advertising and promotional materials for medical devices, drugs, or biologics
- FDA and EU regulated product labeling for medical devices
- Requirements for labeling content including the use of symbols in accordance with ISO standards
- Proficient in Microsoft Office and Adobe
- UDI
- Strong negotiation and communication skills
- Ability to organize and prioritize workflow
- Ability to interact with all levels of employees including senior management
- Strong attention to detail
Experience
- 5 – 10 years medical device regulatory experience with labeling emphasis
- Bachelor degree or higher