Regulatory Affairs Professional CT Image processing software applications

Job description

Job Description - -------------- **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 fast-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