Job Description:
As a Regulatory Compliance Specialist in medical device labeling, you will apply corporate and regulatory requirements to product literature. Your expertise will ensure compliance with FDA code of federal regulations 21CFR parts 820 and 801, as well as the EU MDR regulations governing medical device labeling.
Key Responsibilities:
* Apply corporate and regulatory medical device labeling requirements to product literature
* Manage project information and communicate cross-functionally to lead medical device literature standards and regulation projects
* Author physician and patient medical device product literature deliverables using Adobe InDesign, and work with technical communicators to organize Instructions For Use (IFU) and related product literature
* Interface with third-party translation suppliers to ensure global product literature content is translated accurately per schedule
Requirements:
To succeed in this role, you will need:
* Strong knowledge of FDA regulations and EU MDR guidelines
* Excellent communication and project management skills
* Ability to work with Adobe InDesign and other document creation tools
* Attention to detail and ability to meet deadlines
Benefits:
This role offers a challenging and rewarding opportunity to contribute to the development of high-quality medical device literature. You will be part of a collaborative team that values innovation and excellence.
How to Apply:
To apply for this position, please submit your resume and cover letter.