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If you’re looking to build a career in Regulatory Affairs for medical devices and AI-based healthcare technologies, this opportunity at Harrison.ai is highly strategic. The company is at the forefront of Software as a Medical Device (SaMD) innovation, offering a chance to work on AI-driven diagnostic solutions that directly impact global patient care.
This Regulatory Affairs Specialist job in India (Remote) is ideal for candidates with experience in EU MDR, TGA regulations, and global medical device submissions, especially those interested in AI, machine learning, and digital health products.
Key Responsibilities – Regulatory Affairs Specialist
- Prepare and maintain Technical Files for medical device and SaMD products
- Manage global regulatory submissions (EU MDR, TGA, and other markets)
- Compile and submit regulatory dispatches for product approvals
- Respond to queries from regulatory authorities and notified bodies
- Liaise with authorized representatives and global regulators
- Assess regulatory impact for new products and product changes
- Ensure compliance of product labeling and promotional materials
- Provide regulatory guidance across product lifecycle management
- Handle vigilance reporting and recall notifications
- Stay updated with regulatory intelligence and evolving guidelines
Eligibility & Qualifications
- Degree in Life Sciences, Engineering, Software, or related discipline
- Minimum 2+ years experience in Medical Device Regulatory Affairs
- Strong knowledge of EU MDR and TGA regulatory frameworks
- Experience in global regulatory submissions and compliance
- Excellent attention to detail and ability to manage multiple projects
- Strong cross-functional collaboration and communication skills
Preferred Skills (Nice to Have)
- Experience in Software as a Medical Device (SaMD)
- Exposure to AI/ML-based healthcare products
Why Join Harrison.ai?
- 🌍 Work on cutting-edge AI healthcare technology
- 🤝 Collaborate with global teams across clinical, AI, and engineering domains
- 🚀 Backed by $240M+ funding from top global investors
- 🌱 Career growth with learning budgets, mentorship, and innovation programs
- 💻 Fully remote work flexibility (India-based role)
- 👨👩👧 Inclusive benefits supporting family and life stages
Salary Insight (Estimated)
- 💰 ₹8 LPA – ₹18 LPA (Expected Range)
(Based on industry standards for 2–5 years RA professionals in medical devices & SaMD domain)
How to Apply
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