Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is supporting a leading diagnostics company seeking a Regulatory Affairs Consultant for a remote project. The role focuses on preparing international regulatory submissions and technical documentation for IVD products, supporting global registrations, coordinating with regulatory agencies and distributors, and monitoring project deliverables.
Responsibilities
- Prepare and maintain international regulatory submission dossiers
- Prepare electronic pre-market and post-market regulatory submissions
- Compile technical documentation for IVD medical devices
- Support global expansion and new registrations for diagnostics products
- Work with complex regulatory agencies across the regions listed above
- Monitor project deliverables and provide regular status updates to management
- Support relationships with international customers, including regulatory agencies and distributors
- Apply an understanding of the technical and scientific principles related to MDR/IVD reagent chemistry, laboratory automation, and software components of MDR/IVD medical devices
Skills
- • Recent experience supporting molecular diagnostics and cytology or pathology products
- • Demonstrated experience supporting global expansion and new registrations for diagnostics products
- • Experience working with regulatory agencies in the regions listed above
- • Minimum of 2 years of Regulatory Affairs experience within the IVD space
- • 5+ years of total Regulatory Affairs experience
- BS degree minimum required
Benefits
- Remote work arrangement for the 12-month project
Company Overview
Company H1B Sponsorship