FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm’s artificial intelligence initiative, combines Fujifilm’s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information, please visit healthcaresolutions-us.fujifilm.com.
Job Title: Regulatory Affairs Specialist
This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.
Duties and responsibilities
The position requires the ability to perform the following physical demands and/or have the listed capabilities:
Equal Opportunity Employer
FUJIFILM is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.