About The Role We are seeking a highly skilled Regulatory Affairs Professional specializing in Image processing software applications for Computer Tomography (CT). The ideal candidate will have strong expertise in global regulatory requirements for Software as a Medical Device (SaMD), including submission strategies, software lifecycle compliance, and post-market activities. This role demands close collaboration with R&D; (Software Development), Quality, and Marketing teams to ensure smooth regulatory pathways and post-market compliance.

Key Responsibilities - Lead and execute regulatory submissions CT Image processing software applications across multiple regions, including China, APAC, ASEAN, EU, and others.

- Ensure compliance with global medical device regulations such as MDR (EU), FDA 21 CFR Part 820 (US), and local country-specific regulations.
- Prepare and maintain technical documentation and regulatory dossiers for CT Image processing software applications.
- Support product lifecycle management, including updates, upgrades, and post-market surveillance activities.
- Interface with notified bodies, regulatory authorities, and certification bodies to facilitate product approvals and audits.
- Provide regulatory guidance in software design and development phases to mitigate risks and ensure compliance from early stages.
- Monitor evolving regulations and guidance related to SaMD, AI/ML (if applicable), and cybersecurity, and ensure timely implementation Required Qualifications And Experience - Bachelor's or Master's degree in Life Sciences, Engineering,



or a related field. Advanced degrees or certifications in Regulatory Affairs preferred.
- 3 -6 years of experience in regulatory affairs within the medical device industry, specifically with SaMD.

Experience with China NMPA submissions is an added advantage.

- Proven track record in preparing and submitting regulatory dossiers to notified bodies and regulatory agencies.
- Deep understanding of regulatory frameworks and standards for medical devices and medical software worldwide. Knowledge of Standards and Guidelines (mandatory) - ISO 13485 (Medical devices – Quality management systems)
- ISO 14971 (Application of risk management to medical devices)
- IEC 62304 (Medical device software – Software life cycle processes)
- IEC 62366-1 (Usability engineering for medical devices)
- ISO 14155 (Clinical investigation of medical devices)
- FDA 21 CFR parts 820, 807, and 814 (if applicable)
- Knowledge of MDR (EU) 2017/745
- Understanding of cybersecurity standards for medical devices (e.g., IEC 62443)
- Experience with software validation and verification processes Desired Skills - Excellent communication skills in English; additional language skills (e.g., German) are a plus
- Ability to work cross-functionally in a quick-paced environment
- Detail-oriented with high analytical and problem-solving capability
- Experience with regulatory software submission platforms and tools
- Exposure to or experience with AI-based tools for routine regulatory activities and automation is a plus

📌 Regulatory Affairs Professional CT Image processing software applications (Bengaluru)
🏢 Siemens
📍 Bengaluru