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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
Job ID: 144571793