Registration Engineer

3 days ago

Delhi, India Contec Medical Systems Full time

Regulatory Submissions & Approvals

  • Prepare and submit applications for medical device import/manufacturing licenses to CDSCO.
  • Ensure timely renewal and maintenance of licenses/registrations.
  • Handle product classification (Class A, B, C, D) and compliance as per MDR 2017.
  • EPR registration.

Documentation & Dossiers

  • Compile Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificates, CE/FDA approvals , and other technical documents.
  • Maintain updated records of regulatory submissions and approvals.
  • Respond to CDSCO queries, deficiency letters, and audits.

Liaison & Coordination

  • Act as the point of contact with CDSCO officials, State Licensing Authorities, and Notified Bodies .
  • Follow up on approvals and ensure smooth regulatory interactions.

  • Support internal teams (QA, QC, Production, Marketing, Sales) with regulatory data.

  • Compliance & Vigilance

  • Monitor and implement changes in Indian regulatory guidelines and CDSCO notifications .
  • Ensure compliance with ISO 13485, BIS standards, and Materiovigilance (MvPI) requirements .

  • Maintain proper documentation for audits, inspections, and post-market surveillance.

  • Regulatory Intelligence & Reporting

  • Track and circulate updates on regulatory changes that may impact business.

  • Prepare reports and presentations on the regulatory status of products.

Qualifications & Skills:

  • Bachelor's / Master's degree in Pharmacy, Life Sciences, Biomedical Engineering, or related field.
  • 3 to 6 years of experience in Regulatory Affairs (medical devices preferred).
  • Knowledge of CDSCO, MDR 2017, Drugs & Cosmetics Act, ISO
  • Strong documentation, analytical, and compliance skills.
  • Good communication and liaison skills.
  • Experience with CDSCO's

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