Deputy General Manager- Regulatory/ Quality Assurance

Role Overview

Head QA/RA

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

ISO 13485:2016 Lead Auditor, ISO 14971 (Risk Management), EU MDR 2017/745, US FDA 21 CFR

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

  .