Regulatory Affairs - Medical Devices Citiustech

4.0 - 9.0 years

10 - 20 Lacs

hyderabad, pune, chennai

Hybrid

Key Responsibilities Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices . Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1). Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation). Support risk management , cybersecurity compliance , and software lifecycle documentation . Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements. Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions. Required Skills & Experience 4 to 8 years in regulatory affairs for medical devices, with strong exposure to software and SaMD . Hands-on experience with IEC 62304 , ISO 14971 , and cybersecurity standards (e.g., FDA premarket guidance, IEC 81001-5-1). Proven track record in preparing regulatory submissions for software-based devices. Familiarity with AI/ML regulatory frameworks and real-world evidence considerations is a plus. Strong communication skills to interface with global clients and cross-functional teams. Must Have skill: Regulatory Affairs + SDLC + SaMD Experience: Minimum 4 years Location: Chennai/Pune/Bangalore/Hyderabad/Mumbai Notice: Looking for quick joiners How to Apply: Please send your resume to manojkumar.sampathkumar@citiustech.com with the subject line Regulatory Affairs Specialist along with the following details: Total experience: Relevant experience in Regulatory Affairs: Relevant experience in SDLC / SaMD: Relevant experience in Medical Device: Current CTC: Expected CTC: Notice period: Current Location: Preferred location:

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