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Role Overview:
- This position provides regulatory affairs support to ensure compliance with FDA and international regulations.
- You will be responsible for pre-market submissions and post-market surveillance activities.
- The role involves direct interaction with quality, R&D, and customer service teams.
Key Responsibilities:
- Prepare and submit 510(k) and PMA applications to the U.S. FDA.
- Manage complaint investigations, risk assessments, and field action notifications.
- Support QMS audits and maintain regulatory documentation for MDSAP and EU MDR.
Qualifications:
- Bachelor's degree in a related discipline and 2+ years of regulatory affairs experience in an FDA-regulated environment.
- Broad knowledge of 21 CFR 820, 803, 806, 807, ISO 13485, and ISO 14971.
- Excellent leadership, communication, and organizational skills.
Fujifilm Healthcare Americas Corporation
Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.