* Candidates must have at minimum 2 years of relevant industry experience within CE Mark and International Registrations *
About the Company:
- A privately held company headquartered in San Diego, California.
- Over 360 team members around the world.
- Leaders in the development and commercialization of new autoimmune technologies and diagnostic markers.
- We manufacture IVD systems and reagents that are used in clinical laboratories and hospitals around the world.
Day to day responsibilities:
- Prepare submissions to EU regulatory entities to obtain CE Mark. Create and maintain product EU Technical Files.
- Reviews design history files, device history records and any documentation associated with the development and/or enhancement of product, or requests from appropriate department as needed additional technical documentation, to create/maintain Technical Files and support regulatory filings and CE mark submissions and updates.
- Create and maintain regulatory database.
- Prepare, collect or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
- Review product labeling, advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Review product changes to impact on regulatory filings worldwide.
- Bachelor's degree with at least 2 years of relevant industry experience within Regulatory Affairs.
- Competent in Class II device required.
- Knowledge of International medical device regulatory requirements required.
- Demonstrated experience with ISO and QSRs as applicable to medical devices preferred
- Broad Knowledge in Microsoft tools like Excel, Word, PowerPoint preferred.
- Experience in creating and maintaining EU Technical files.
Sthree US is acting as an Employment Agency in relation to this vacancy.