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
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Lead and execute regulatory submissions CT Image processing software applications across multiple regions, including China, APAC, ASEAN, EU, and others.
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Ensure compliance with global medical device regulations such as MDR (EU), FDA 21 CFR Part 820 (US), and local country-specific regulations.
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Prepare and maintain technical documentation and regulatory dossiers for CT Image processing software applications.
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Support product lifecycle management, including updates, upgrades, and post-market surveillance activities.
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Interface with notified bodies, regulatory authorities, and certification bodies to facilitate product approvals and audits.
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Provide regulatory guidance in software design and development phases to mitigate risks and ensure compliance from early stages.
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Monitor evolving regulations and guidance related to SaMD, AI/ML (if applicable), and cybersecurity, and ensure timely implementation
Required Qualifications and Experience
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Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. Advanced degrees or certifications in Regulatory Affairs preferred.
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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.
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Proven track record in preparing and submitting regulatory dossiers to notified bodies and regulatory agencies.
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Deep understanding of regulatory frameworks and standards for medical devices and medical software worldwide.
Knowledge of Standards and Guidelines (mandatory)
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ISO 13485 (Medical devices – Quality management systems)
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ISO 14971 (Application of risk management to medical devices)
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IEC 62304 (Medical device software – Software life cycle processes)
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IEC 62366-1 (Usability engineering for medical devices)
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ISO 14155 (Clinical investigation of medical devices)
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FDA 21 CFR parts 820, 807, and 814 (if applicable)
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Knowledge of MDR (EU) 2017/745
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Understanding of cybersecurity standards for medical devices (e.g., IEC 62443)
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Experience with software validation and verification processes
Desired Skills
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Excellent communication skills in English; additional language skills (e.g., German) are a plus
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Ability to work cross-functionally in a fast-paced environment
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Detail-oriented with high analytical and problem-solving capability
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Experience with regulatory software submission platforms and tools
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Exposure to or experience with AI-based tools for routine regulatory activities and automation is a plus
