SaMD, Regulatory, MULTIPLE ROLES

3 days 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.

  • Regulatory Engineer

    9 hours ago


    Bengaluru, Karnataka, India Cyient Full time ₹ 35,00,000 - ₹ 70,00,000 per year

    ResponsibilitiesLead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC , IEC , ISO , ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations.​Analyze historical Request for Change (RfS) and design change...

  • Senior QMS

    1 week ago


    Bengaluru, Karnataka, India easyqQ Solutions And Technologies Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    About the RoleWe are seeking a SaMD QMS & Regulatory Expert to lead quality and regulatory activities with a specific focus on FDA compliance and IEC 62304 software lifecycle management. This role is central to ensuring that our Software as a Medical Device (SaMD) products meets all applicable U.S. FDA regulatory requirements while maintaining a robust,...

  • Multiple Roles

    5 hours ago


    Bengaluru, Karnataka, India The KariGhars Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    We're hiring for multiple roles at The KariGhars in Bangalore. If you have experience in interior design and are looking to be part of a fast-paced, design-driven environment, we'd love to hear from you.Open Positions – Main Vertical (Interior Design experience is mandatory):Pre-Sales Consultant – 1Shopping Evangelist – 1Interior Stylist – 1Channel...


  • Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job ID473488Posted since13-Oct-2025OrganizationSiemens HealthineersField of workQuality ManagementCompanySiemens Healthcare Private LimitedExperience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Bangalore - Karnataka - IndiaThe Head of Regulatory Affairs will lead the regulatory function for...


  • Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and...


  • Bengaluru, Karnataka, India AliveCor Full time US$ 1,00,000 - US$ 1,50,000 per year

    DescriptionAt AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered...


  • Bengaluru, Karnataka, India Bolster Legal Services Pvt Ltd Full time ₹ 2,16,000 - ₹ 3,60,000 per year

    Walk-In Interviews – Multiple U.S. Legal Roles | Night Shift | Cox Town, BengaluruSalary: ₹18,000 – ₹30,000/month (based on role & experience)Why Join Bolster Legal?Grow your career in U.S. legal operations with a stable, professional team. Learn specialized skills, interact with U.S. clients, and enjoy career growth opportunities—all while working...

  • Regulatory Reporting

    11 hours ago


    Bengaluru, Karnataka, India Deutsche Bank Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    **Job Description:Job Title: Regulatory Reporting - AVPLocation: Bangalore, IndiaRole DescriptionThe role is to perform a number of key functions that support and control the business in complying with a number regulatory requirements such as MiFID II, EMIR and SFTR .This role forms part of a team in Bangalore that supports Regulatory reporting across all...


  • Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...


  • Bengaluru, Karnataka, India GSK Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Site Name: Bengaluru Luxor North TowerPosted Date: Oct Job Title: Regulatory Associate Manager - Product Variations, CD CMCBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...