Regulatory, Quality & Distribution Operations Professional …, Haryana

Regulatory, Quality & Distribution Operations ( Medical Devices) Work Flexibility: Onsite Job Profile Regulatory, Quality & Distribution Operations (Medical Devices)
- Ensure end-to-end compliance with ISO 13485:2016, Medical Devices Rules, 2017, and Drugs and Cosmetics Act, 1940 across warehouse and distribution operations
- Maintain audit-ready documentation and regulatory certifications to support internal, external, and authority inspections
- Drive implementation and governance of Valuable Distribution Practices (GDP) for medical devices, ensuring product integrity throughout the supply chain
- Manage Quality Management System (QMS) processes including Change Controls, Deviations, CAPAs, and Non-Conformances
- Ensure complete product traceability through accurate documentation (invoices, delivery challans, batch/lot tracking, stock records)
- Oversee inventory governance by enforcing FIFO/FEFO, cycle counts, and reconciliation to achieve 100% inventory accuracy
- Coordinate with QA for product release, incoming inspections, and pre-dispatch quality checks to ensure compliance and role clarity
- Ensure proper storage, handling, and environmental controls (temperature, humidity, cleanliness) as per product specifications
- Lead execution and closure of product recalls, field safety corrective actions (FSCA), and quality holds in compliance with regulatory timelines
- Manage regulatory compliance related to pricing and labeling, including NPPA-driven MRP revisions and documentation control
- Ensure adherence to applicable regulations such as Drug Price Control Order (DPCO), Plastic Waste Management Rules, 2016, and Hazardous Waste Management Rules, 2016
- Operate and optimize ERP systems (JDE, IROS) for efficient warehouse, inventory, and distribution management
- Drive operational excellence in warehouse activities including receiving, storage, dispatch, and logistics coordination
- Ensure compliance with occupational health, safety, and infrastructure standards, including AMC/CMC management and warehouse upkeep
- Conduct training and capability-building programs on SOPs, regulatory updates, and medical device handling to ensure organization-wide compliance Education / Work Experience:
- BS in Biotechnology, Bioengineering, Science/Pharma, or related degree; or MS in Regulatory Science
- Typically a minimum of 3-4 years experience
- MS or RAC(s) preferred Knowledge / Competencies:
- Project management, writing, coordination, and execution of regulatory items
- Perform technical and scientific regulatory activities
- Usually works with minimum supervision, conferring with superior on unusual matters
- Assignments are broad in nature, requiring originality and ingenuity
- Has some latitude for unreviewed action or decision
- Seeks out diverse ideas, opinion, and insights and applies them in the workplace
- Connects and relates well with people who think and act differently than oneself
- Embraces scrutiny and accepts feedback as opportunity to learn and improve
- Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
- Navigates the dynamics, alliances, and competing requirements of the organization or business
- Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities Travel Percentage: 20% Apply on Kit Job: kitjob.in/job/4n5utw