Lead Drug-Device Combination Product Development

1 day ago

Ahmedabad, Gujarat, India beBeeMedicalDevice Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Title: Senior Manager for Device Development

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The Senior Manager / Deputy General Manager will be responsible for overseeing the development of complex drug-device combination products, including auto-injectors, pen injectors, and inhalers.

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Key Responsibilities:

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  • Provide strategic direction and governance for device development projects, ensuring alignment with corporate objectives and regulatory strategy.">
  • Manage multi-disciplinary teams to lead design, validation, and lifecycle management of drug-device combination products.">
  • Ensure robust Design History Files (DHFs) and Design Control documentation per US FDA 21 CFR Parts 210/211/820, EU MDR, and ISO standards.">
  • Drive risk management frameworks to ensure safety, compliance, and product robustness.">
  • Direct the development of URS, validation protocols, and V&V processes for manufacturing and functional test systems.">
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Required Skills & Competencies:

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  • 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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Qualifications:

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  • Bachelor's degree in Mechanical Engineering or related field (required).">
  • MBA from a top college is a plus.">
  • Master's degree in Engineering Design, Medical Device Design, or related discipline.">
  • Experience in medical device development (drug delivery preferred).">
  • Minimum 10 years of experience in the pharmaceutical/medical device industry.">
  • Minimum 5-7 years in people management / leadership roles, with demonstrated P&L and program delivery accountability.">

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