We are looking for a Senior Medical Devices Specialist with strong expertise in Medical Devices (MD), In Vitro Diagnostics (IVD), and Combination Products to join our Life Sciences Regulatory Intelligence team. The ideal candidate will have a solid background in medical device regulatory affairs, quality systems, or compliance, and a passion for delivering high quality, accurate, and actionable regulatory intelligence.
You will be responsible for monitoring global regulatory changes, interpreting complex technical requirements, and ensuring the accuracy and consistency of CRI’s Medical Device and IVD content. Your ability to apply subject matter expertise, work within AI enhanced editorial workflows, and collaborate across global teams will be essential to supporting users navigating evolving regulatory frameworks.
About You – experience, education, skills, and accomplishments
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.
It would be great if you also had . . .
Prior experience in regulatory intelligence or regulatory content development.
Familiarity with ISO standards, risk management (ISO 14971), and conformity assessment pathways.
Experience interacting with notified bodies or regulatory authorities.
Knowledge of medical device lifecycle management and vigilance/post‑marketing surveillance practices.
Understanding of AI/ML‑enabled medical device regulatory considerations.
What will you be doing in this 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.
About the Team
As part of Regulatory Market Access, the Regulatory Intelligence team consists of subject‑matter experts responsible for monitoring and curating global regulatory content across the full medicinal product, medical device and IVD lifecycle. The team collaborates closely with Product, Tech, and Customer Care, Product Specialists/Account Managers to deliver trusted insights that support regulatory, compliance, and market access decisions. The team is spread across different locations: France, Malaysia, India, Serbia, Spain.
Hours of Work
Hybrid work mode (Monday to Friday). The work timing is 8-9AM / 5-6PM IST
Location: Hyderabad.
At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
Top Skills
Clarivate Analytics Chennai, Tamil Nadu, IND Office
No.148, Acropolis, CIT Colony Dr. Radhakrishnan Salai, Mylapore , Chennai, Tamil Nadu, India, 600004
