Regulatory, Quality and Distribution Operations Specialist - Medical Devices

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 Good 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%