Regulatory Affairs Specialist for Medical Devices in India

1 week ago


Delhi, Delhi, India Danaher Full time
Job Summary

We are seeking an experienced Regulatory Affairs Specialist to join our team in India. The ideal candidate will have a strong background in medical devices regulation, excellent analytical and problem-solving skills, and the ability to work effectively in a matrix organization.

About the Role

The Sr. RA Specialist will be responsible for initiating and preparing regulatory submissions, interacting with Business Units Regulatory affairs teams, and communicating with regulatory agencies/health authorities to obtain and maintain product approvals.

Main Responsibilities:
  • Prepare and submit product Import license applications, renewals, and Post Approval change applications.
  • Coordinate with Business Units Regulatory Affairs team to request documents for applications.
  • Respond to queries raised by the Regulatory authority against submitted applications.
  • Meet project timelines and provide proactive regulatory intelligence.
  • Collaborate with cross-functional departments to complete process for products requiring in-country testing data.
  • Provide regulatory assessments for anticipated changes.
  • Manage Regulatory Stop Ships for registered products.
  • Offer regulatory guidance on labeling and promotional materials preparation.
Requirements

To be successful in this role, you should have:

  • A degree in a science/Pharmacy or related field.
  • At least 8-10 years of experience within registration process in medical devices or IVD industry.
  • In-depth knowledge of Indian and other jurisdiction regulatory requirements.
  • Experience in working in a matrix organization and international environment.
  • Strong analytical and problem-solving skills, as well as interpersonal skills with emphasis on diplomacy and negotiation.
  • Ability to multitask, prioritize, and meet deadlines in a timely manner.
About Danaher

Danaher brings together science, technology, and operational capabilities to accelerate real-life impact. We partner with customers across the globe to help them solve complex challenges and architect solutions that bring the power of science to life. Our global teams pioneer what's next across Life Sciences, Diagnostics, Biotechnology, and beyond.



  • Delhi, Delhi, India FICCI Full time

    FICCI, a prominent industry chamber, seeks an experienced Regulatory Affairs Specialist to join their team. This individual will play a crucial role in supporting the organization's work related to the medical devices and equipment sector.The ideal candidate will have a strong understanding of policies and regulations in the medical devices sector, as well...


  • Delhi, Delhi, India Nipro Medical India Full time

    Job Summary:Nipro Medical India Pvt Ltd is seeking a skilled Medical Device Compliance Specialist to manage and oversee the complaint handling process for our medical devices.Key Responsibilities:Manage the intake, investigation, and resolution of customer complaints related to medical devices.Ensure compliance with CDSCO regulations, ISO standards, and...


  • Delhi, Delhi, India ELT Corporate Private Limited Full time

    Job Title: Medical Device Registration Sales ExecutiveLocation: —Department: Regulatory Affairs / SalesReports to: Sales Manager Job Summary: —We are seeking a sales professional to drive revenue growth by identifying opportunities in the regulatory & compliance industry in India. The ideal candidate should have a strong understanding of sales processes,...


  • Delhi, Delhi, India Nipro Medical India Full time

    Job Title: Medical Device Complaint Resolution SpecialistAbout Us:Nipro Medical India Pvt Ltd is a leading medical device manufacturing company dedicated to providing innovative and high-quality products that improve patient outcomes. We are committed to maintaining the highest standards of quality and compliance in our operations.Job Summary:We are seeking...


  • Delhi, Delhi, India ELT Corporate Private Limited Full time

    Job Title: Clinical Sales Specialist - Medical Device RegistrationAt ELT Corporate Private Limited, we are seeking a skilled Clinical Sales Specialist to join our team. This role will be responsible for driving revenue growth by identifying and converting new business opportunities in the regulatory & compliance industry in India while ensuring customer...


  • Delhi, Delhi, India Nipro Medical India Full time

    About Nipro Medical IndiaNipro Medical India Pvt Ltd is a subsidiary of Nipro Corporation Japan, a leading medical device manufacturing company dedicated to providing innovative and high-quality products that improve patient outcomes.We are committed to maintaining the highest standards of quality and compliance in our operations. Our team strives for...


  • Delhi, Delhi, India Viggo Medical Devices Full time

    Viggo Medical Devices, a leading manufacturer of specialized medical devices, seeks a skilled Medical Device Sales Representative to join its team. With a strong presence in the global market, Viggo is dedicated to providing high-quality products and services to patients, hospitals, and life science research institutions.About Viggo Medical...


  • Delhi, Delhi, India Dozee Full time

    Job SummaryWe are seeking an experienced Medical Device Regulation Specialist to join our team at Dozee, a leading AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) company. This role is responsible for ensuring compliance with regulatory requirements, developing and implementing quality management systems, and providing...


  • Delhi, Delhi, India ELT Corporate Private Limited Full time

    Job Summary:We are seeking a highly motivated Medical Device Sales Professional to join our dynamic team at ELT Corporate Private Limited. As a key member of our sales force, you will play a crucial role in driving revenue growth by identifying and converting new business opportunities in the regulatory & compliance industry in India.The ideal candidate...


  • Delhi, Delhi, India ELT Corporate Private Limited Full time

    Job Title: Regulatory Affairs SpecialistAbout Us:ELT Corporate Private Limited is a leading consultancy specializing in Compliance, Registrations, Licensing, and Legal Services. Our areas of expertise include handling regulatory requirements for import-export, Medical Device Registration, Legal Metrology, Environmental Regulatory Compliance, BIS...


  • Delhi, Delhi, India ELT Corporate Private Limited Full time

    We are seeking a highly motivated and results-driven Sales Executive to join our growing team at ELT Corporate Private Limited.The ideal candidate will have a strong understanding of sales processes and CRM systems, with excellent written and verbal communication skills in English.Job DescriptionThis role is responsible for driving revenue growth by...


  • Delhi, Delhi, India Viggo Medical Devices Full time

    Viggo Medical Devices, a pioneering medical device manufacturing company, is seeking an exceptional Sales Executive to spearhead business growth in key territories.We are dedicated to delivering cutting-edge solutions for infusion therapy, anesthesia, critical care, respiratory care, and urology. Our team collaborates closely with hospitals' IPD user groups...


  • Delhi, Delhi, India Staffing Support India Full time

    About Staffing Support IndiaWe are a leader in the medical device industry, committed to enhancing patient care through cutting-edge technology and design.Job Summary:We are seeking an experienced Mechanical Engineer/Draftsman to support our medical device product development team. The ideal candidate will have expert proficiency in SolidWorks and be capable...


  • Delhi, Delhi, India Staffing Support India Full time

    Staffing Support India is seeking an experienced Product Development Engineer to join our medical devices team in the United States.Job Summary:We are looking for a skilled Product Development Engineer with expertise in SolidWorks and experience in solid modeling, complex assemblies, and detailed drawings. The ideal candidate will have a strong understanding...


  • Delhi, Delhi, India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full time

    We are seeking an experienced Regulatory Affairs Manager to join our team in India. This role involves developing regulatory strategies, managing submissions, ensuring compliance, and collaborating with cross-functional teams to drive product success in the Indian market.Key Responsibilities:Regulatory Strategy and Planning: Develop and implement effective...


  • Delhi, Delhi, India ARDEM Data Services Full time

    Job OverviewWe are seeking a highly skilled Medical Data Analyst to join our team at ARDEM Data Services. This role is essential in ensuring the accuracy, quality, and compliance of medical documents with regulatory standards.About the RoleDocument Review: Conduct thorough reviews of various medical documents, including clinical trial reports, regulatory...


  • Delhi, Delhi, India Lifelancer Full time

    About Vodafone Idea LimitedVodafone Idea Limited is a leading telecom service provider in India, partnering with the Aditya Birla Group and Vodafone Group. We provide pan-India voice and data services across 2G, 3G, and 4G platforms.We're committed to delivering delightful customer experiences and contributing to creating a truly 'Digital India' by enabling...


  • Delhi, Delhi, India Excelya Full time

    Excelya is a leading Contract Research Organization (CRO) in Europe, founded in 2014 with its headquarters in Paris. With over 900 experts globally, the company provides trial solutions across various therapeutic areas. Excelya's one-team approach to work ensures that collaboration is at every stage of a project, from regulatory affairs and clinical...


  • Delhi, Delhi, India ARDEM Data Services Full time

    Job DescriptionA Medical Document Quality Assurance Specialist at ARDEM Data Services plays a pivotal role in ensuring the accuracy, quality, and compliance of medical documents. This position is ideal for individuals with a strong attention to detail and excellent communication skills.ResponsibilitiesDocument Review: Conduct thorough reviews of various...


  • Delhi, Delhi, India WHO Full time

    **Job Overview**The World Health Organization (WHO) is seeking a highly skilled Medical Devices and Diagnostics Specialist to support the development of national policies on improving access to essential diagnostics and medical devices. This role will involve strengthening systems and capacities related to the development of essential diagnostic / devices...