Regulatory Affairs Specialist
Katalyst Healthcares & Life Sciences
4 days ago
Remote
Role Summary:
Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.
Key Responsibilities:
Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.
Key Responsibilities:
- Support execution of regulatory project plans.
- Compile and prepare global regulatory submissions.
- Review technical and scientific data supporting submissions.
- Prepare responses to questions from regulatory authorities.
- Maintain regulatory files and documentation.
- Assist with labeling, SOPs, and departmental documents.
- Track regulatory submission/documentation status.
- Edit and proofread regulatory documents.
- Participate in cross-functional project teams.
- Manage multiple regulatory projects and priorities.
Must-Haves:
- Experience with medical devices / healthcare regulatory affairs.
- Knowledge of U.S. and OUS device regulations, especially EU regulations.
- Experience developing or supporting Regulatory Affairs strategies.
- Experience working with cross-functional teams.
- Experience interacting with external regulatory authorities, such as FDA and TUΜV.
- Bachelor's degree in a relevant scientific discipline or equivalent experience.