Job Summary
A technology company is seeking a Telecommute Regulatory Affairs Specialist.
Core Responsibilities of this position include:
- Providing regulatory compliance guidance to drive global initiatives
- Developing and maintaining technical documentation (technical files)
- Identifying issues that need resolution to ensure continued registrations in all global markets
Must meet the following requirements for consideration:
- Ability to travel 5% annually with possibly some international
- 5+ years of experience in international and US FDA 510(k) regulatory submissions
- 5+ years of experience writing and assembling technical documentation files or design dossiers
- Deep knowledge about new EU MDR and differences to MDD
- Knowledge of regulatory requirements for CE marking and UDI
- Experience in associated regulations relevant to labeling and use of international symbols
