Quality Assurance Regulatory Affairs Manager

7 hours ago


Kolkata, West Bengal, India ELESONIC GROUP Full time ₹ 9,00,000 - ₹ 12,00,000 per year

**Company Description

Elesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray and C-arm machines. By 2019, Elesonic expanded its operations to African Union through offices at Nigeria and Uganda. Same Year in 2019 Elesonic established a presence in Canada for Trans atlantic operation including Carribean Islands. Our pledge is to deliver quality and exceptional service in the industry. Join us in making the world a healthier place

Role Description

This is a full-time, on-site role for a Quality Cum Regulatory Assurance Executive located in Kolkata. The role involves overseeing and implementing quality control and assurance processes, conducting quality audits, and managing quality systems. The executive will ensure compliance with regulatory standards and work closely with various departments ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment.

Qualifications

  • Implementing and acheiving Quality Control, Quality Assurance, and Quality Management skills Experience in Quality Control and Quality Assurance processes
  • Proficiency in Quality Management systems and practices
  • Knowledge of Medical Device Regulations (i.e - AERB / BIS / CDSCO / ISO 13485 European / CE European )
  • Strong analytical and problem-solving skills
  • Excellent attention to detail and organizational abilities
  • Ability to work effectively in a team and independently
  • Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Quality Management
  • Must Have Physics one of the Subject in Bachelor's Degree
  • Radiological Safety Officer ( RSO ) Exam from AERB passed is preffered and if not passed then have the ability to pass
  • Prior experience in the medical equipment industry is a plus**


  • Kolkata, West Bengal, India Elesonic Group Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Role DescriptionImplementing quality control and assurance processes ensure compliance with regulatory standards ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment.Health insuranceAnnual bonusProvident fund

  • Regulatory Officer

    2 weeks ago


    Kolkata, West Bengal, India JK Spices & Food Full time ₹ 4,50,000 - ₹ 6,00,000 per year

    Regulatory Officer – QC & QADepartment: Quality Control & Quality AssuranceLocation: DhulagarhKey Responsibilities:Regulatory Compliance:Ensure compliance with FSSAI, Legal Metrology, BIS, and other relevant food regulations.Prepare and submit documents for product registration, renewals, and licensing.Monitor regulatory updates and ensure timely...


  • Kolkata, West Bengal, India Techsprout Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    Company DescriptionTarinika is a jewelry brand originating from a family of traditional jewelers. With a wide appreciation for their unique selections in India, Tarinika aims to bring the love for jewelry across the sea, starting with the USA. They participate in The International Gem and Jewelry Show organized every week throughout the United States, where...


  • Kolkata, West Bengal, India Hyland Software Full time ₹ 18,00,000 - ₹ 25,00,000 per year

    OverviewJob Description: The Quality Assurance Manager 4 is responsible for supporting the quality framework testing tools and technologies policy standards and practices landscape across the company's product suites. This is a shared services role that supports the compliance and accountability activities of teams on quality oversight as it occurs...


  • Kolkata, West Bengal, India CLIRNET Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    AMedical Affairs Managerwill develop and execute medical strategies, ensuring scientific and regulatory compliance, and serving as a medical expert for internal and external stakeholders.About the RoleKey responsibilities involve managing clinical trial activities, creating and approving promotional materials, and building relationships with healthcare...


  • Kolkata, West Bengal, India Techsprout Ai Labs Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Responsibilities:* Lead quality assurance processes from planning to execution.* Ensure compliance with industry standards and customer requirements.* Monitor performance metrics and identify improvement opportunities.


  • Kolkata, West Bengal, India Ligasure Healthcare Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    JD's :Regulatory Strategy: ROW Market Expansion,CTD/eCTD Dossiers,Registrations,Renewals,Variations,CDSCOCompliance & Audits: Regulatory Audits,Inspections,Artwork Compliance,Promotional Materials,Risk MitigationMail-Annual bonus

  • Quality Manager

    2 days ago


    Kolkata, West Bengal, India CogentHubCX Full time ₹ 70,000 - ₹ 1,30,000 per year

    Location: KolkataDepartment: Quality Assurance / Process ExcellenceIndustry: BPO / Call Center / Telecom / Customer ServiceEmployment Type: Full-timeJob Summary:We are hiring a detail-oriented and experienced Quality Manager for our Telecom BPO operations in Kolkata. The ideal candidate will lead the Quality Assurance function, drive process improvements,...

  • Quality Assurance

    3 days ago


    Kolkata, West Bengal, India PEOPLE POWER Full time ₹ 30,000 - ₹ 3,50,000 per year

    Job Responsibilities:Monitor and ensure product quality at all stages of production (cutting, stitching, finishing, and packing).Conduct inline and final inspections of garments to ensure compliance with buyer specifications.Develop and implement quality assurance procedures, standards, and guidelines.Identify defects, analyze root causes, and recommend...


  • Kolkata, West Bengal, India SSP Solutions Full time

    Quality Risk ManagementBatch Manufacturing Record preparationProcess ValidationAnnual Product Quality ReviewCleaning ValidationBatch card preparationDossier PreparationChange Control ManagementDocuments preparationNew Drug Application Required Candidate profileExperience in Quality Assurance in Pharma IndustryGender FemaleLocation South Kolkata