The RA/QA Manager is responsible for overseeing regulatory compliance and quality assurance functions to ensure all products meet internal and external quality standards, as well as regulatory requirements. This role includes managing audits, documentation, CAPA, Quality Compliance, Investigation, Product registration, and implementation of quality management systems (QMS). Expertise in Conducting internal Audit and support in external audit (India/international). Experience in Deviation Management, Product recall and required procedures. Key Responsibilities Develop, implement, and maintain regulatory and quality assurance strategies and systems. Ensure compliance with applicable local and international regulatory requirements (e.g., FDA, ISO, CE, GMP). Lead and prepare for internal and external audits (regulatory bodies, customers). Oversee preparation and submission of regulatory dossiers for product registration and market approval. Coordinate with R&D and production teams to ensure product quality throughout the lifecycle. Review and approve SOPs, validation protocols, batch records, and technical documentation. Train team members on quality and regulatory standards and updates. Monitor and report on quality metrics, non-conformances, and continuous improvement initiatives. Qualifications Bachelor's or Master’s degree in Pharmacy, Life Sciences, Engineering, or related field. Knowledge of medical device regulations and quality standards (e.g.- FDA 21 CFR Part 820, ISO 13485) 7+ years of experience in Quality Assurance and/or Regulatory Affairs in the pharmaceutical, medical device or manufacturing industry. Strong understanding of GMP, ISO standards, and regulatory guidelines. Excellent communication, leadership, and organizational skills Show more Show less

About Arni Medica Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, cleanroom production, and new product development. We are expanding our production team and seeking an experienced Production Line In-Charge to oversee assembly operations, ensuring efficiency, quality, and compliance with industry standards. Key Responsibilities Oversee daily assembly operations on the production line, ensuring smooth workflow and target achievement. Supervise and coordinate production workers, providing guidance and training as needed. Ensure compliance with GMP, ISO 13485, and company quality standards. Monitor production schedules, optimize manpower allocation, and minimize downtime. Conduct quality checks at various assembly stages and report deviations. Collaborate with the QC and maintenance teams to resolve process issues. Maintain proper documentation, batch records, and production logs. Implement continuous improvement initiatives to enhance productivity and efficiency. Qualifications & Skills Education: Diploma/B.Tech in Mechanical, Electrical, or Biomedical Engineering. Experience: 2-5 years in medical device, pharmaceutical, or similar regulated manufacturing environments. Strong knowledge of assembly processes and cleanroom operations. Ability to manage teams and meet production targets. Familiarity with quality control processes and documentation. Proficiency in troubleshooting production issues and implementing corrective actions. Strong leadership, problem-solving, and communication skills.

Job Duties Product Sales and Marketing: To Achieve Sales Objectives using marketing skills effectively to generate the demand and business from doctors Demonstrating or presenting demo of the products to healthcare staff including Doctors, nurses, and pharmacists To promote critical care range of Medical devices to Doctors, Hospital Pharmacist, Stockiest, Distributors and achieve maximum marketing Organizing appointments and meetings with community and hospital-based healthcare staff Assess clients’ needs and present suitable promoted products Monitor and analyse data and market conditions to identify competitive advantage Ability to develop Customer Relationship To ensure proper implementation of marketing strategies Daily updating stock details to the higher management. Product Marketing And Market Research Appoint Distributors in the assigned Regions and negotiate contracts Plan and implement the most effective distributor & Dealer Network for placement of Company Products in the market Identify market needs & capture through product & brand line extension with the support of product development team Identify opportunities in the market through new channel creation & ensure product availability in that region Design schemes for Trade & execute in the market to achieve organizational goals Analyse sales data & implement necessary models to ensure analytics driven decision making Assess clients’ needs and present suitable promoted products Monitor and analyse data and market conditions to identify competitive advantage Candidates with an experience in a Medical devices company are preferred

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 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.