EU MDR Regulatory Content Specialist
1 day ago
About DEV-X Consulting LLC
DEV-X Consulting LLC is a leading provider of medical device regulatory consulting services. Our team of experts helps clients navigate the complex EU MDR landscape and ensure compliance with all relevant regulations.
Job Summary
We are seeking a highly skilled EU MDR Regulatory Content Specialist to join our team. In this role, you will be responsible for coordinating the EU MDR program work for claims with other copy review workstreams such as active CAPAs. You will also update global Surgical Technique Guides and promotional materials to all standards using compliant communication process.
Key Responsibilities
* Coordinate the defined cadence of the EU MDR program work for claims with other copy review workstreams such as active CAPAs.
* Update global Surgical Technique Guides and promotional materials to all standards using compliant communication process.
* Lead and manage routings including STG, promotional materials and claims.
* Create and approve claims collection and substantiation and approval.
* Manage all asset edits with vendor and create proof within stated budget and timeline.
* Complete and approve associated F-S813 (Design Evaluation Form) to support EOS routing.
* Manage EOS routing and complete approval process for STGs, promotional materials and claims.
* Store and redistribute final approved assets.
Requirements
* Must have Medical Device Experience within EU MDD and/or EU MDR.
* Strong knowledge of EU MDR regulations and guidelines.
* Excellent communication and project management skills.
What We Offer
* Competitive salary: $80,000 - $100,000 per year.
* Opportunities for professional growth and development.
* Collaborative and dynamic work environment.
How to Apply
If you are a motivated and detail-oriented individual with experience in EU MDR regulatory consulting, please submit your application.
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