Senior Regulatory Compliance Manager

1 week ago


Delhi, Delhi, India Nulife Full time

The Company Overview

Nulife, an ISO-13485 certified medical disposables company, has been serving humanity for 59 years. Headquartered in Mumbai, we have 4 locations across India with a network of more than 3000 channel partners. Our products are sold globally in over 80 countries and enjoy a global reputation for products that offer superior protection, high levels of comfort and performance.

Our Products Compliance

We comply with all the global standards like European CE mark under the new MDR (Medical Device Regulation), US510(k), South Korea GMP, etc.

Job Description - Senior Regulatory Compliance Manager

Key Responsibilities

  • Maintain regulatory files and ensure compliance with regulatory authorizations, including euMDR, 510(k), UCKA PPE & medical device licenses.
  • Ensure the Quality Management System complies with the Drugs and Cosmetics Act, Medical Device Rule 2017 & Medical Device Regulations.
  • Manage internal and external audits, inspection readiness, and Regulatory Authority inspections.
  • Ensure personal and company compliance with local regulations, policies, and procedures.
  • Manage the complete PMS (post-market surveillance) process.
  • Managed product and process risk management, clinical evaluation, product verification, and validation.
  • Provide training to concerned employees related to ISO, MDR, GMP, and Medical device regulations as per EU and assessment.
  • Audit and assess device-related incidents/complaints for medical device reporting requirements.
  • Compile and submit reportable events to relevant regulatory authorities on time.
  • Review and approve translations of product labelling and promotional material.
  • Ensure compliance with Environmental regulations.

Education Requirements

B. Pharmacy/M. Pharmacy/B.Sc. /M.Sc.

Skills and Qualifications

Audit management euMDR, ISO13485 and 510K.

Work Experience

5 years to 10 years

Languages

English, Hindi and Gujrati



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