FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Salary Distribution
5 of 7 jobs
$38
Min
$5,000
25th
$91,200
Median
$130,909
75th
$164,000
Max
Benefits Overview
5 of 7 jobs
Dental
(5)
Life Insurance
(5)
Medical
(5)
Vision
(5)
401K
(2)
401k
(2)
PTO
(2)
401(k)
(1)
Paid Time Off
(1)
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
Identify and establish relationships with Key Accounts and Opinion Leaders in the Liver/Hepatology Medical Oncology community to drive sales of HCC Risk Biomarkers.
Maintain comprehensive understanding of IVD reagent systems, distribution modalities, and clinical performance to educate Healthcare Professionals on screening and surveillance benefits.
Deliver sales goals by exploring growth opportunities, removing barriers, and adjusting strategy based on insights and market data.
Manage reprocessing and infection control activities for the endoscopic product portfolio, serving as the primary company resource and subject matter expert.
Work cross-functionally with customers, third-party companies, and internal stakeholders to ensure reprocessing recommendations satisfy US market needs and comply with industry guidelines.
Develop validation programs, technical manuals, and educational tools while representing the company on national committees and keeping leadership informed of trends.