Project Summary
We are seeking an early career Health Regulatory professional, with experience and degree-level training in the field of Software as a Medical Device. This person will join a team of raters to review and classify whether outputs from a Generative AI large language model (LLM) would be classified as a medical device or not. The team will be led through a series of exercises before individually delivering the final dataset.
Project Details
Expected workload
Weexpect 24 - 32 hours total work per rater including onboarding, calibration/ feedback meetings and evaluation work.
Training - 5 hours.
Adjudication/ feedback meetings - 1 hours
Eval work - 16-24 hours.
Responsibilities
Your main responsibility will provide ratings for responses and help shape the evaluation process. This involves:
- Guideline Understanding & Ratings: Gaining a comprehensive view of the health regulatory evaluation task, understanding the evaluation guidelines, and thinking critically about responses and ratings.
- Providing Consistent Ratings: Being able to evaluate a high volume of responses across a broad range of topics consistently.Collaborate with key stakeholders: Communicate with various team members to discuss ratings and adjudicate responses as needed.
Requirements
Required Qualifications
- Bachelor’s degree or higher in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related discipline.
- 5+ years of regulatory affairs experience in medical devices, with proven SaMD regulatory experience.
- Strong knowledge of regulatory frameworks relevant to SaMD in either Japan, UK, EU or Australia
- Demonstrated success preparing and managing regulatory submissions.
- Excellent analytical writing, communication, and stakeholder collaboration skills.
Native for the selected country that is to be evaluated and assessed during the work, and fluent English for communication with the team.
Preferred Qualifications
- RAC (Regulatory Affairs Certification) or similar credential.
- Experience with regulatory compliance software and document management systems.
- Familiarity with risk management (ISO 14971), software lifecycle standards (IEC 62304), and quality systems (ISO 13485).
- Demonstrated experience navigating multi-region approvals.
If you are interested in this position, please use the button. You may email recruiting@medcase.health with any questions you might have.
Our team will be in contact with you with more information.
If you are interested in this position, please use the button. You may email recruiting@medcase.health with any questions you might have.
Our team will be in contact with you with more information soon.
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