Job
Description
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
