Job Opportunity: Regulatory Affairs Specialist (Remote, India)

Job Summary

Harrison.ai is seeking a detail-oriented and strategic Regulatory Affairs Specialist to join our growing team. As a leader in the development of Software as a Medical Device (SaMD) and AI-driven diagnostic solutions, we are transforming global patient care. This is a fully remote position based in India, ideal for a professional with a strong foundation in medical device regulations, including EU MDR and TGA frameworks. You will play a pivotal role in ensuring our innovative products meet global compliance standards while supporting our mission to scale high-impact healthcare technologies.

Responsibilities

As a Regulatory Affairs Specialist, you will manage the end-to-end regulatory lifecycle of our products. Your key responsibilities will include:

• Technical Documentation: Prepare, review, and maintain comprehensive Technical Files for medical devices and SaMD products.
• Global Submissions: Lead and manage global regulatory submissions, ensuring compliance with EU MDR, TGA, and other international market requirements.
• Regulatory Correspondence: Act as the primary point of contact for regulatory authorities and notified bodies; draft and submit responses to inquiries and regulatory dispatches.
• Strategic Compliance: Provide expert regulatory guidance throughout the product lifecycle, assessing the impact of new product developments and modifications to existing devices.
• Collaboration: Liaise effectively with authorized representatives and global stakeholders to ensure seamless market access.
• Labeling and Promotion: Ensure all product labeling, packaging, and promotional materials strictly adhere to regulatory guidelines.
• Quality and Vigilance: Oversee vigilance reporting and manage recall notifications as required.
• Regulatory Intelligence: Stay current on evolving regulatory landscapes, guidelines, and industry standards to maintain the company’s competitive edge.

Requirements

We are looking for a candidate who is passionate about digital health and possesses the technical expertise to navigate complex regulatory environments.

Essential Qualifications:

• Education: A degree in Life Sciences, Engineering, Software, or a related discipline.
• Experience: A minimum of 2+ years of professional experience in Medical Device Regulatory Affairs.
• Regulatory Knowledge: Deep understanding of EU MDR and TGA regulatory frameworks.
• Project Management: Proven ability to manage multiple submissions simultaneously with a high degree of accuracy and attention to detail.
• Communication: Excellent interpersonal skills with the ability to collaborate effectively across cross-functional teams, including clinical, AI, and engineering departments.

Preferred Skills (Nice to Have):

• Practical experience with Software as a Medical Device (SaMD) products.
• Direct exposure to AI/ML-based healthcare technologies.

Benefits

Joining Harrison.ai means being part of a well-funded, mission-driven organization. We provide an environment that fosters innovation and personal growth:

• Impact: Contribute to cutting-edge AI healthcare technology that influences global patient outcomes.
• Collaboration: Work with world-class, multidisciplinary teams across clinical and technical domains.
• Stability: Join a company backed by $240M+ in funding from top-tier global investors.
• Growth: Access to professional development opportunities, including learning budgets and mentorship programs.
• Flexibility: Enjoy the freedom of a fully remote work model.
• Wellness: Comprehensive benefits packages designed to support your work-life balance and individual life stages.

Salary Range

The expected salary for this role is ₹8 LPA – ₹18 LPA, commensurate with industry standards and the candidate’s experience in medical devices and the SaMD domain.

How to Apply

If you are ready to advance your career in regulatory affairs and contribute to the future of AI in healthcare, please submit your application via the official Harrison.ai careers portal. We look forward to reviewing your qualifications and discussing how your expertise can support our innovative team.

[Please visit the official Harrison.ai careers page to submit your resume and application.]