General Manager (Medical Device Manufacturing)

medical device

Key Responsibilities

• Strategic Leadership:
• Assume leadership and full P & L responsibility for the respective group/verticals. Prepare annual budget and Track project budgets and timelines.
• Develop and execute strategic plans to achieve organizational objectives and growth targets.
• Align operational goals with the company’s vision and mission.
• Identify and evaluate new business opportunities, partnerships, and market trends.
• Operations Management:
• Oversee all aspects of operations, including production, supply chain, procurement, and logistics, ensuring efficiency and cost optimization.
• Monitor performance metrics and implement process improvements to meet production goals and maintain quality standards.
• Ensure smooth coordination between departments for seamless workflow and timely delivery of products.
• Statutory Compliance:
• Ensure full compliance with local, national, and international regulatory requirements, including ISO 13485, ISO 9001, MDR, and CDSCO regulations.
• Maintain up-to-date knowledge of statutory requirements (ESI, ePF, GST, PT, RBI, FCGPR and Customs-import/export) and implement necessary changes in processes or documentation.
• Manage licensing, certifications, and regulatory submissions in coordination with the Regulatory Affairs team.
• Quality Assurance and Control:
• Lead initiatives to maintain and enhance product quality standards.
• Oversee implementation and adherence to quality management systems (QMS) and handle internal and external audits.
• Drive continuous improvement programs for product and process quality.
• Tender Management:
• Manage the identification, preparation, and submission of tender applications to secure government and private contracts.
• Collaborate with finance and legal teams to ensure tenders are aligned with company policies and meet compliance requirements.
• Maintain relationships with tendering authorities and track tender statuses to capitalize on opportunities.
• Subsidy and Grant Applications:
• Oversee the preparation, documentation, and submission of subsidy and grant applications with relevant authorities.
• Stay updated on government schemes, financial incentives, and policies applicable to the medical device and healthcare sectors.
• Work closely with financial and legal teams to ensure timely and accurate filing of subsidy claims.
• Team Leadership and Development:
• Build, mentor, and manage high-performing cross-functional teams.
• Define clear roles, responsibilities, and performance metrics for employees.
• Conduct regular performance reviews and implement training programs to enhance team capabilities.
• Financial and Resource Management:
• Prepare and manage operational budgets, ensuring financial discipline and profitability.
• Monitor financial performance and implement corrective actions to achieve targets.
• Oversee procurement and inventory management to optimize costs and prevent shortages.
• Statutory and Legal Operations:
• Ensure adherence to labor laws, environmental regulations, and health and safety standards.
• Manage company compliance with statutory bodies, including tax filings, audits, and certifications.
• Collaborate with legal teams to handle contracts, agreements, and other legal matters.
• Project Management:
• Lead and manage critical projects from initiation to completion, ensuring timelines, budgets, and deliverables are met.
• Anticipate project risks and develop mitigation strategies.
• Foster collaboration among stakeholders to ensure successful project execution.
• Stakeholder Engagement:
• Build and maintain strong relationships with clients, regulatory authorities, and business partners.
• Represent the company in industry forums, client meetings, and conferences.
• Market Intelligence and Innovation:
• Monitor industry trends, competitive landscape, and emerging technologies.
• Provide strategic insights for product innovation and market expansion.
  

Key Skills

• Strong leadership and operational management skills.
• Expertise in tender and subsidy management processes.
• In-depth knowledge of regulatory frameworks and statutory compliance.
• Proven expertise in managing production, supply chain, and quality functions.
• Excellent communication, negotiation, and interpersonal abilities.
• Proficiency in financial management, project planning, and ERP systems.
• Strong analytical and problem-solving skills with a focus on continuous improvement.
  

Preferred Qualifications

• MBA or advanced degree in business administration or healthcare management.
• Hands-on experience in the medical device or pharmaceutical industry.
• Cleanroom Injection Moulding, Extrusion, joint assembly followed with ETO sterilization
• Certification in Lean Manufacturing, Six Sigma, or related methodologies is a plus.