Regulatory Affairs Specialist – BIS & NABL Compliance Expert

3 years

0 Lacs

Posted:11 hours ago| Platform: Linkedin logo

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Company Description

ELT Corporate Pvt. Ltd. is a leading regulatory affairs and compliance consulting firm offering end-to-end services in BIS certification, NABL accreditation, CDSCO registration, EPR authorization, WPC license, and FDA regulatory support. We serve clients across manufacturing, healthcare, electronics, and environmental industries, helping them achieve full compliance for market access in India and abroad.


Role Description

We are seeking an experienced BIS and NABL expert who can independently manage end-to-end certification and accreditation processes. The ideal candidate should have hands-on experience with BIS (ISI, CRS, FMCS) registration, NABL laboratory accreditation, and a working understanding of other regulatory areas such as CDSCO, EPR, WPC, and MDR.


Key Responsibilities

  • Handle ISI Mark Certification, CRS registration, and FMCS licensing for Indian and foreign manufacturers.
  • Prepare applications, coordinate with labs, and liaise with BIS officials for audits and renewals.
  • Review product testing reports and ensure conformity to relevant IS standards.
  • Prepare documents and assist testing/calibration labs for ISO/IEC 17025 accreditation
  • Coordinate with NABL assessors for on-site assessments and closure of NCs.
  • Guide laboratories in implementing quality systems as per NABL guidelines.
  • Support other regulatory verticals (knowledge of the following is preferred):
  • CDSCO (medical device/cosmetic registration)
  • EPR (Plastic/Battery/Waste Authorizations)
  • WPC (ETA & Import Licenses)
  • FDA/Drug Licenses
  • Draft technical files, compliance checklists, and audit documentation.
  • Monitor changes in standards, QCO notifications, and BIS/NABL circulars.
  • Work closely with internal teams and clients to ensure project timelines and quality.


Qualifications

  • Bachelor's or Master’s degree in a relevant field of study
  • Experience in the regulatory field, especially in BIS & NABL compliance, is an advantage
  • Skills in Regulatory Documentation and Regulatory Submissions
  • Strong knowledge of Indian Standards (IS codes), QCO notifications, and testing requirements.
  • Good documentation, communication, and coordination skills.


Preferred Skills

  • Exposure to CDSCO, EPR, WPC, or MDR projects.
  • Understanding of product testing workflows and lab compliance requirements.
  • Ability to coordinate with clients, labs, and authorities professionally.
  • Experience using Zoho CRM or other project management tools (advantageous).


Why Join ELT Corporate

  • Work with a pan-India compliance consulting leader.
  • Get exposure to multi-sector regulatory projects and global clients.
  • Attractive compensation, incentive structure, and growth pathway.
  • Opportunity to become a lead consultant or regulatory manager within a year based on performance.

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