Development Manager

2 weeks ago

Ahmedabad, Gujarat, India beBeeManagement Full time ₹ 2,24,44,800 - ₹ 2,59,04,000
Job Title

Sr. Manager / Deputy General Manager, Drug Delivery Systems Development

Job Description

We seek an experienced and skilled Sr. Manager to lead our drug delivery systems development.

This role involves managing multi-disciplinary teams, providing technical and managerial ownership of complex work streams, and driving business outcomes.

Key Responsibilities
  • Leadership & Strategic Management:
    • Provide vision, direction, and governance for assigned device development projects.
    • Manage internal staff, global partners, and contract resources.
    • Define strategic priorities, budgets, and timelines.
  • Program & Technical Ownership:
    • Lead the design, validation, and lifecycle management of combination products.
    • Ensure Design History Files (DHFs) and Design Control documentation.
    • Drive risk management frameworks to ensure safety, compliance, and product robustness.
  • Cross-Functional Leadership:
    • Lead structured cross-functional reviews with R&D, Formulation, Operations, QA, RA, and Supply Chain.
    • Actively manage relationships with contract manufacturers, automation partners, and regulatory agencies.
  • Team Development & Capability Building:
    • Mentor and coach engineering managers and design engineers.
    • Establish best practices in design-for-manufacturing (DFM), design-for-assembly (DFA), and advanced risk assessment methodologies.
Requirements
  • Technical Mastery:
    • Advanced expertise in GD&T, SolidWorks, injection molding, intricate mechanism design, DHF documentation, and V&V processes.
  • Regulatory Rigor:
    • Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14971 and related medical device regulatory frameworks.
  • Risk & Quality Leadership:
    • Demonstrated authority in leading risk assessments, CAPA management, and quality-by-design initiatives.
  • Executive Communication:
    • Ability to influence senior executives and regulatory bodies through clear, concise, and authoritative communication.
  • Change Leadership:
    • Proven track record of driving organizational change, building scalable processes, and aligning cross-functional teams.

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