About Radformation
Automation solutions for efficient cancer treatment planning
Key Highlights
- Serves over 1,300 clinics globally
- Raised $9.2 million in funding
- Offers automated 3D planning and billing review tools
- Headquartered in Midtown East, New York
Radformation, founded in 2013 and headquartered in Midtown East, New York, is dedicated to enhancing cancer treatment through intelligent automation. With over 1,300 clinics utilizing its solutions, Radformation offers a comprehensive suite of products including automated 3D planning, billing review...
🎁 Benefits
Radformation offers self-managed PTO, top-tier medical, dental, and vision benefits, and hosts virtual events for team engagement. The company operate...
🌟 Culture
Radformation's culture is centered around reducing clinicians' administrative burdens through user-friendly automation solutions. The company values i...
Regulatory Affairs Specialist • Senior
Overview
Radformation is hiring a Senior Regulatory Affairs Specialist to ensure their Software as a Medical Device products meet global regulatory requirements. You'll work closely with cross-functional teams to support regulatory strategy and compliance. This role is fully remote within the United States.
Job Description
Who you are
You have a strong background in regulatory affairs, particularly in the medical device sector, with a focus on Software as a Medical Device (SaMD). Your experience includes coordinating regulatory registrations and renewals across multiple countries, ensuring compliance with both U.S. and international regulations. You are detail-oriented and possess excellent communication skills, allowing you to effectively collaborate with cross-functional teams and regulatory bodies.
You understand the complexities of the regulatory landscape and are adept at navigating the requirements for medical devices. Your ability to analyze regulatory changes and their impact on product development is crucial. You are committed to patient safety and quality care, aligning with Radformation's mission to improve cancer treatment.
What you'll do
In this role, you will coordinate multi-country regulatory registrations and renewals for new and modified SaMD medical devices. You will work closely with the VP of Regulatory Affairs and Principal Regulatory leadership to guide regulatory strategy for product changes. Your responsibilities will include preparing and submitting regulatory documentation, ensuring compliance with applicable regulations, and supporting the timely delivery of innovative cancer care technology.
You will also play a key role in scaling regulatory processes as the company grows, contributing to the development of best practices and standard operating procedures. Your work will directly support patient safety and regulatory compliance, making a significant impact on the quality of care delivered to patients.
What we offer
Radformation offers a fully remote work environment, allowing you to contribute to our mission from anywhere in the United States. You will be part of a mission-driven team dedicated to transforming cancer care through innovative technology. We provide opportunities for professional growth and development, ensuring that you can advance your career while making a meaningful impact in the healthcare industry.
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