Regulatory Affairs Sr. Specialist - Clinical Usability
Benefits
Unlimited PTO
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Why This Role Matters:
- Play a key role in ensuring Radformation's Software as a Medical Device products meet global regulatory requirements.
- Bring a deep expertise in SaMD regulatory expectations, including FDA guidance and EU MDR requirements.
- Help drive completion of critical usability and clinical deliverables.
Responsibilities Include:
- Develop an efficient and effective Usability program.
- Lead the construction and execution of both formative and summative usability activities.
- Author or revise SOPs to improve regulatory compliance of the Quality System.
Required Experience:
- 8+ years of regulatory affairs experience with a Bachelor's degree
- Software as a medical device (SaMD) experience
- Experience in creating or contributing to usability studies
Radformation
Radformation is transforming the way cancer clinics deliver care. Their innovative software automates and standardizes radiation oncology workflows. They are a fully remote, mission-driven team united by a shared goal to reduce cancer’s global impact and help save lives.