Arni Medica is a leading medical device manufacturer specializing in contract manufacturing new product development and high-quality production of nephrology and healthcare products.
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 companys 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.