Sr Executive QA(RA&NPD)

1 day ago

Noida, Uttar Pradesh, India Talent Vision Services Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Job Purpose:
  • Responsible for updating QMS procedures, creating new documents and updating Quality Manual with regard to latest guidelines/regulatory requirements/applicable product standards.
  • Responsible for product submissions – domestic and international, registration renewals, seeking periodic updates and dossier preparation for regulatory agencies.
  • Organize regulatory information, track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide and research regulatory issues and provide guidance to colleagues.
Functional Responsibilities:
  • Timely compile Product Technical Files/ QA records required for renewals, updates and registrations.
  • Update and maintain UDI (GTIN) barcode log sheet and registration certificates log sheet – client wise.
  • Maintain regulatory files /database and chronologies in good order.
  • Review art designs and labels for compliance with regulatory and customer requirements.
  • Review changes to existing products and processes to define the requirements for regulatory submissions.
  • Routinely review changes in the regulatory framework such as USFDA, EU, ROW, CIS, India etc. and product standards ,update the list of product standards in a timely manner, wherever applicable.
  • Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements are met throughout the development process.
  • Complete submissions to all countries wherever products are expected to be launched / placed in the market.
  • Keeping self, regularly updated through subscriptions and relevant online forum updates.
  • Actively pitch-in daily QA department affairs, participate and contribute in inter-departmental requests.
Competencies
  • B.Tech/B. Pharma/B.Sc with 3-5 yrs of experience in Regulatory Affairs /Quality Assurance.
  • Any certification or full time course in Regulatory Affairs/QA
  • Knowledge of Quality Management Systems and regulations e.g. ISO 13485, ISO 9001, 21 CFR 820, MDR 745.
  • Fair communication skills and computers skills, able to work with basic MS office
  • Experience in Medical device Industry will be a bonus.
  • Result orientation
  • Customer-centricity

Rev. 05 Effective Date: Page 1

Reporting to: AGM

Department: Quality Assurance

Relevant Experience: 3- 5 Years

Position: Sr. Executive - QA (RA & NPD)

  • NPD Engineer

    2 weeks ago

    Greater Noida, Uttar Pradesh, India Bajaj Carpet Industries Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role OverviewWe are seeking a driven and eager NPD Engineer to join our New Product Development (NPD) team. The role involves management of new project initiatives in automotive nonwovens, insulation felts and interior part development. The successful candidate will support the NPD department by contributing to design, prototyping, validation, and successful...

  • Procurement Specialist

    2 weeks ago

    Noida, Uttar Pradesh, India Naari Pharma Pvt Ltd. Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    About Us:Naari Pharma is a B2B pharmaceutical company dedicated exclusively to advancing women's health. With a sharp focus on hormonal therapies, we manufacture high-quality finished dosage forms for global markets. Our products are present in over 60 countries, including key regulated territories such as the US, Canada, Europe, and Australia.Backed by a...

  • SR. QA Engineer

    4 days ago

    Noida, Uttar Pradesh, India Benthon Labs Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Profile- QA Engineer (Manual+ Automation)Experience yearsLocation - Noida Sec- 62Skills - Selenium, Java, TestNg, XPath, API testing, Database TestingRole DescriptionThis is a full-time on-site role for a Senior QA Engineer (Manual+Automation) located in Noida. The Senior QA Engineer will be responsible for carrying out daily tasks such as executing software...

  • Senior Tender Executive

    2 days ago

    Noida, Uttar Pradesh, India Webmobril technologies Private Limited Full time ₹ 3,90,000 - ₹ 40,55,100 per year

    Full job descriptionPrior experience in GeM portal operations and government tendering portals is a must.Good understanding of tender documentation and procedures.Good communication and coordination skills.Attention to detail and ability to manage deadlines.Should have knowledge of the Gem portal for tender SubmissionKnowledge of Ra auction in Gem...

  • Salesforce QA Engineer

    3 days ago

    Noida, Uttar Pradesh, India NTT DATA Global Delivery Services Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Digital Solution Cnslt. Sr. Consultant We are seeking a highly skilled Salesforce QA Engineer with strong expertise in automation testing using the Karate framework. The ideal candidate will have hands-on experience in Salesforce Service Cloud, Omni-Channel, Case Routing, CTI flow, and Agentforce, along with a proven track record in testing integrations...

  • Sr. Executive

    2 weeks ago

    Noida, Uttar Pradesh, India ROI Mantra Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionROI Mantra is a Google All-Star award-winning, profit-driven digital marketing agency with its delivery center based in Noida, India. As a certified Google Premier Partner Agency, ROI Mantra employs data-driven strategies to significantly boost client customer acquisition and revenue. Our team of 100+ digital experts works on direct client...

  • DC2025028 || Sr. QA Engineer || Noida

    22 hours ago

    Noida, Uttar Pradesh, India Droisys Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job DescriptionAbout the RoleWe are looking for a Senior Quality Assurance (QA) Engineer to join our fast-paced product development team. The ideal candidate will be responsible for ensuring the delivery of high-quality software by designing test strategies, creating automation frameworks, executing test cases, and mentoring junior QA engineers. You will...

  • Sr HR Executive

    2 weeks ago

    Noida, Uttar Pradesh, India Mobilab (by Primary Healthtech) Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionMobilab (by Primary Healthtech) is a National Startup Award Winner focused on pioneering affordable and accessible next-generation healthcare diagnostics. With support and funding from various institutions, including MeitY, DBT, DST, and AIIMS Delhi, we are committed to advancing predictive diagnostics. Our mission is to offer early...

  • CA0209 - Sr SDET

    2 weeks ago

    Noida, Uttar Pradesh, India CloudAngles Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    About the RoleWe are looking for a highly skilled Senior SDET to join our Product Delivery Team. The Sr. SDET will be responsible for ensuring product quality through test automation, functional validation, and proactive defect identification. This role requires strong problem-solving skills, a deep understanding of system architecture, and the ability to...

  • Sr. Executive

    3 days ago

    Noida, Uttar Pradesh, India MAK BUILDING SYSTEM PVT. LTD. Full time ₹ 3,00,000 - ₹ 4,50,000 per year

    Job Title: Sr. Executive / Assistant Manager – AccountsCompany: Mak Building System Pvt. Ltd.Location: Noida, Sector-62Interview - walk in - 8th, 9th, 10th October 2025 at our corporate office- B-805, Noida One Tower, Sector- 62, Noida Contact us Experience: 4–10 Years in Accounts & FinanceEmployment Type: Full-TimeCTC: As per industry standards (based...