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Job Description

About Connected Health

Connected Health is a Division of Tata Industries developing clinically accurate, user-friendly point-of-care diagnostic devices for home use. Our mission is to bridge the gap between consumer-friendly wearables and clinical-grade medical devices, creating solutions that enable preventive, predictive, and personalized healthcare.

Our current product pipeline includes devices focused on Non-Communicable Diseases such as hypertension, diabetes and aging related ailments.

Role Overview

We are seeking a qualified professional to support our warehouse and regulatory compliance operations. This individual will ensure all storage, handling, and distribution activities for medical devices comply with CDSCO regulations under the Medical Devices Rules, 2017, including requirements for MD42 (Wholesale License).

Key Responsibilities

Regulatory Compliance

Ensure all medical device storage, handling, and distribution activities comply with Medical Devices Rules, 2017

Maintain all required documentation and records as per CDSCO guidelines for MD42 (Wholesale License)

Support coordination for regulatory inspections and audits

Stay updated on changes to medical device regulations and ensure organizational compliance

Warehouse & Quality Operations

Oversee proper storage conditions and inventory management of medical devices

Ensure maintenance of batch records, distribution records, and recall procedures

Implement and monitor quality control systems for device handling

Manage complaint handling and adverse event reporting as required

Assist in preparing and maintaining documentation for regulatory filings

Operational Coordination

Coordinate with manufacturing, supply chain, and quality teams on compliance matters

Support vendor qualification and management from a regulatory perspective

Assist in developing standard operating procedures (SOPs) for device handling

Provide training to team members on regulatory requirements and compliance

Essential Qualifications

Mandatory Requirements (as per CDSCO MD42 norms):

Maharashtra state Registered Pharmacist (B.Pharm / D.Pharm / M.Pharm)

Atleast 1-year experience working at an organization holding MD42 or Form 20-21B

Additional Requirements:

Understanding of Medical Devices Rules, 2017 and CDSCO guidelines

Immediate Joiner

Experience with regulatory documentation and compliance procedures

Knowledge of Good Distribution Practices (GDP) and Good Warehouse Practices (GWP) for medical devices

Excellent attention to detail and documentation skills

Ability to interact with regulatory authorities

Preferred Qualifications

Prior experience in medical device warehouse or distribution operations

Familiarity with ISO 13485 or other medical device quality standards

Experience with CDSCO inspections and audits

Knowledge of import/export procedures for medical devices

Understanding of post-market surveillance requirements

Behavioural Attributes

Meticulous & Detail-Oriented: Regulatory compliance demands precision

Integrity & Ethics: Uncompromising on compliance and quality standards

Proactive Problem-Solver: Ability to anticipate and address compliance issues

Good Communication: Effectively liaise with regulatory authorities and internal teams

Adaptability: Comfortable in a startup-like environment within a larger organization

Why Join Us

Be part of a mission to transform healthcare through innovative technology

Play a critical role in ensuring our products meet the highest regulatory standards

Opportunity to build compliance frameworks for potentially life-changing products

Collaborative environment with exposure to product development and operations

5-day work week with sensible hours in our Mumbai office

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Job ID: 144571793