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 rapid-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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Affairs Professional (Bengaluru)
🏢 Siemens Healthcare
📍 Bengaluru