Regulatory and Quality

23 hours ago

Delhi, India NMD Placement Consultancy Full time

Job Role - Software As Medical devices SME Location- Pune Experience - 6 to 10 Years Bachelor’s degree in relevant field (or equivalent experience) 6 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred. Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus. Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections. SAMD, SIMD IS MUST Mandate keyskills: FDA Submissions SAMD 510(k) EUAI Act ISO 13485 Auditors certification (external preferred) Regulatory SUBHADEEP 9830203229 CTC :MAX 25 L

  • Quality Assurance Regulatory Affairs Manager

    3 weeks ago

    New Delhi, India Frido Full time

    Key Responsibilities: Location: Pune Regulatory Compliance: Ensure adherence to ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification standards. Quality Management Systems (QMS): Implement and maintain robust QMS to comply with regulatory standards. Technical Documentation: Prepare and review technical files for regulatory submissions, ensuring...

  • Regulatory Affairs Officer

    2 hours ago

    Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time

    Regulatory Affairs Specialist - Legal Metrology and EPR India **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest Legal Metrology and EPR regulations in India. Ensure that all products and processes comply with these regulations. Documentation: Prepare and maintain all necessary documentation required for regulatory submissions,...

  • Regulatory SME

    3 weeks ago

    Delhi, India Tata Consultancy Services Full time

    Location: PAN INDIA Experience should be between 5 to 10 years CA, CFA, MA in Economics or MBA Finance Roles and responsibilities: Functional Areas: Enhance and develop the Regulatory process with close co-ordinations with client stakeholders. Identify opportunities and develop new ideas that will lead to improvements. Understanding the Scope of Data and...

  • Gm - Regulatory

    4 days ago

    Delhi, Delhi, India Vodafone Idea Full time

    Job Req ID: 47563 - Location: New Delhi, IN - Function: Other - About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing demand for...

  • Head of Quality and Regulatory Compliance

    4 weeks ago

    New Delhi, India Getinge Full time

    Job Overview:The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

  • Head of Quality and Regulatory Compliance

    3 weeks ago

    New Delhi, India Getinge Full time

    Job Overview: The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

  • Head of Quality and Regulatory Compliance

    2 weeks ago

    New Delhi, India Getinge Full time

    Job Overview: The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

  • Head of Quality and Regulatory Compliance

    2 days ago

    New Delhi, India Getinge Full time

    Job Overview:The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

  • Quality Surveyor

    3 weeks ago

    New Delhi, India Thaswikha Exports and Imports Full time

    Company Description Thaswikha Exports and Imports is one of the major Rice Exporter from India. Our Company is incorporated in the Year 2016 and annual turnover of around 500 million Rupees.Role Description This is a full-time on-site role for a Quality Surveyor, located in Chennai. As a Quality Surveyor, your daily tasks will include conducting quality...

  • GM – Quality

    4 weeks ago

    New Delhi, India LOXIM Industries Limited Full time

    Title:GM – Quality & Regulatory Affairs (Pharmaceutical API & Intermediate) Location:Ahmedabad, Gujarat Experience:> 15 years in API Quality & Regulatory roles, including leadership positions Education:M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMSince its inception in 1977,LOXIM INDUSTRIES LIMITEDhas grown to become...