Job Title: Operations Officer -Regulatory Affairs and Quality Assurance (Medical Devices) Department: Regulatory Affairs and Quality Assurance Reports To: Manager, Regulatory & Quality Summary: The Regulatory Affairs and Quality Assurance Specialist plays a critical role in ensuring medical devices comply with relevant regulations and quality standards. They are responsible for the preparation, submission, and maintenance of regulatory documentation, ensuring adherence to ISO 13485 quality management system requirements, and contributing to the overall quality and safety of medical devices. Responsibilities: Regulatory Affairs: Prepare, compile, and submit regulatory dossiers for medical devices to international regulatory agencies (e.g., FDA, EMA). Develop and maintain regulatory strategies to support product approvals and market access. Monitor and interpret regulatory changes and guidelines, assessing their impact on the company's products and processes. Maintain current knowledge of relevant regulations, standards, and guidance documents related to medical devices. Prepare technical files, design dossiers, and other regulatory documentation as required. Communicate with regulatory agencies and notified bodies on submissions, inquiries, and audits. Quality Assurance: Implement and maintain a robust quality management system (QMS) in accordance with ISO 13485 requirements. Develop and maintain quality system procedures, work instructions, and forms. Verify medical device documents filled by the design and development department and communicate back changes. Conduct internal audits to ensure compliance with the QMS and regulatory requirements. Participate in external audits by regulatory agencies and notified bodies. Manage and investigate customer complaints and quality issues, ensuring appropriate corrective and preventive actions (CAPA) are taken. Contribute to the development and implementation of risk management activities for medical devices. Qualifications and Experience: A Bachelor's degree with 1 year of experience or a Master's degree with 2 years of experience in Biomedical Engineering, focusing on regulatory affairs and/or quality assurance in the medical device industry. Demonstrated knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and other relevant standards. Experience with preparing and submitting regulatory dossiers for medical devices. Strong understanding of risk management principles and quality system processes. Excellent written and verbal communication skills. Ability to work independently and collaboratively within a cross-functional team environment. Detail-oriented with strong organizational and problem-solving skills. Salary Range: Rs 25200 - Rs 33600 + (Out campus allowance) Location: BETIC, IIT Bombay, Mumbai, Maharashtra, India Note: Candidates with a background in the Medical Device industry are encouraged to apply.
Job Title
Operations Officer - Regulatory and QA