Description
In this position, you will:- Prepare worldwide regulatory submissions for new devices and modified devices as required
- Work efficiently with project development teams and obtain deliverables for US and international submissions to meet regulatory requirements
- Provide RA strategies/plan, guidance and assessments to project team members during new product development, and sustained engineering projects
- Coordinate and prepare responses to FDA Deficiency Letters and other foreign health authorities' requests. Corresponded with FDA to discuss agency comments and follow-up on submissions
- Prepare and managed STED documents, Technical Files/Essential Requirements to gain CE mark and foreign registration submissions
- Review and assess regulatory impacts for the product design/process change on regulatory filings for Class II devices
- Review and approve device labeling and advertising materials and assured compliance with applicable US and international regulatory requirements
- Analyze and recommend appropriate changes and adding of supporting data and ensured the consistency with approved claims
- Collaborate with US & OUS corporate RA partners to support global submissions of new product registration and re-registration of existing products
Qualifications:
- 3+ years of regulatory affairs experience working for a medical device company
- International regulatory experience
- Experience working on 510(K) clearances for the FDA
- Bachelor's degree
- Dental device experience a plus
- Master's degree a plus
To find out more about Real please visit www.realstaffing.com