Deputy General Manager- Regulatory/ Quality Assurance

5 days ago

Bahadurgarh, India Mediplus Full time

Role Overview

The Head QA/RA will be responsible for leading Regulatory Affairs (RA) and Quality Assurance (QA) functions to ensure compliance with Indian & International medical device regulations (MDR 2017, EU MDR 2017/745, US FDA 21 CFR, ISO This role will be pivotal in driving product approvals, managing audits, and maintaining the highest standards of product quality and regulatory compliance.

Role & responsibilities

Regulatory Affairs (RA):

  1. Submission of documents to State FDA & CDSCO, New Delhi for approval of additional domestic/export products.
  2. Renewal of Drug Manufacturing License as per statutory requirements.
  3. Arrange FSC, Non-Conviction Certificate, QMS Certificates from State FDA Haryana.
  4. Implement Medical Device Rules (MDR) 2017 across the organization.
  5. Ensure compliance with export country regulatory requirements.
  6. Coordinate & prepare for FDA and Notified Body inspections for grant/renewal of manufacturing and loan licenses.
  7. Implement EU MDR 2017/745 regulations within the organization.
  8. Communicate with MOH (overseas authorities) & Local FDA for adverse events related to medical devices.
  9. Issue FSCA (Field Safety Corrective Action) & FAN (Field Advisory Notice) in case of adverse events.
  10. Provide required regulatory documents to Marketing for product registration with overseas customers.

Quality Assurance (QA):

  1. Report all quality issues and decisions to the General Manager.
  2. Ensure end-to-end product quality from raw material to finished goods.
  3. Oversee validation & revalidation of production processes and machines.
  4. Investigate and resolve customer complaints effectively.
  5. Lead CAPA (Corrective & Preventive Actions) initiatives across departments.
  6. Minimize residual risk of products through effective control measures.
  7. Manage safe disposition of non-conforming products.
  8. Handle product recalls & returned goods in line with compliance standards.
  9. Approve and monitor deviation requests.
  10. Review incoming, in-process, and final inspection records as per Quality Plans.

Preferred candidate profile

  1. Certifications in ISO 13485:2016 Lead Auditor, ISO Risk Management), EU MDR 2017/745, US FDA 21 CFR Highly Desirable

  2. Hands-on experience in Indian MDR 2017, EU MDR 2017/745, US FDA regulations, ISO 13485 audits.

Key Skills:

  • Strong knowledge of medical device regulatory frameworks.
  • Expertise in ISO 13485 QMS and audit management.
  • Excellent leadership & cross-functional collaboration skills.
  • Strong problem-solving, analytical, and decision-making abilities.
  • Excellent communication skills for dealing with regulators, auditors, and international authorities.

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