SaMD, Regulatory, MULTIPLE ROLES

1 week ago

Bengaluru, Karnataka, India QualBizz Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per year

QualBizz is looking for Immediate joiners for its client. Email to

5+ years
of experience with
multiple positions.

SME
level 15 + experience,
one position

Hybrid, Bangalore Location

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
  • 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

  • 5– 15 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
  • 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.

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