
Senior STEM Content Analyst
Clarivate
full-time
Posted on:
Location Type: Hybrid
Location: Hyderabad • India
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Job Level
Tech Stack
About the role
- Monitor and assess global regulatory changes across ICH regions, FDA, EU MDR/IVDR, and LATAM/APAC authorities
- Interpret complex regulatory updates and convert them into accurate, reliable, and actionable intelligence for CRI users
- Provide authoritative subject-matter expertise to guide, validate, and enhance AI-assisted content generation processes
- Ensure contextual accuracy, consistency, and quality across all editorial outputs, both automated and manually curated
- Uphold CRI’s editorial standards, contributing to the development and refinement of quality-control processes
- Collaborate with AI-supported workflows to accelerate coverage and improve production efficiency
- Mentor and support junior team members, strengthening the team’s regulatory and editorial capabilities
- Contribute to cross-functional initiatives, working closely with Product, Technology, and Customer-facing teams
- Participate in special editorial projects, content improvements, and operational enhancements.
Requirements
- Bachelor’s degree in a relevant scientific, engineering, or technological field
- Minimum 5 years of experience in medical device or IVD regulatory affairs, regulatory intelligence, quality systems, or related roles
- Strong knowledge of global regulatory frameworks across ICH regions, including FDA, EMA, and emerging LATAM and APAC markets
- Deep understanding of device classifications, clinical and performance evidence requirements, PMS/PMPF frameworks, and QMS standards (e.g., ISO 13485)
- Expertise in emerging domains such as Software as a Medical Device (SaMD), cybersecurity expectations, and Real World Evidence use in medical devices
- Proven ability to interpret and translate complex regulatory developments into clear, actionable insights
- Experience working with or reviewing AI-assisted editorial or content generation tools
- Strong communication, analytical, and problem-solving skills, with a high level of accuracy and attention to detail
- Ability to work effectively in global, cross-functional, and remote teams
- Fluency in English; additional languages are a plus.
Benefits
- Hybrid work mode
- Equal employment opportunities for all qualified persons
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsregulatory intelligencequality systemsdevice classificationsclinical evidence requirementsperformance evidence requirementsPMS frameworksPMPF frameworksQMS standardsISO 13485
Soft Skills
communicationanalytical skillsproblem-solvingattention to detailmentoringcollaborationteamworkcross-functional collaborationadaptabilityleadership