RA/QA Manager

About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor and submit applicable reports and appropriate responses to the local health authorities Interact with the local health authorities in during the review process to ensure timely regulatory approval Ensure compliance with product post marketing approval conditions. Complete all training as required and maintain training plans, records, etc. Support and/or participate as necessary in quality compliance audits. Maintain the organization and the security for all regulatory paper and electronic files. Manage product lifecycle maintenance such as product license renewal, listings, change control notifications, etc. Review, comment and approve/disapprove change controls request that may affect the marketing of products. Provide content for local labelling in accordance with local regulation and registration approval and work with relevant parties to release and maintain the local labelling. Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities. Review, approve/disapprove product labeling, advertising and promotional request, field communications, etc. Prepare and submit all reporting activities associated with a removal or correction with the local health authorities Maintain and timely update new product listings, product delisting, registration of new manufacturing sites, etc. into the relevant registration and listing databases. Support to commercial team in providing regulatory documents required for reimbursement and tender applications. Communicate regulatory issues that may impact the marketing of the products to internal stakeholders. Act as the company focal point for interaction with various government agencies in response to queries from the agencies. Skills & experience Bachelor’s degree in science or relevant field Minimum of at least 3 – 5 years of experience in medical device regulatory affairs is required. Related experience and knowledge in regulatory submissions to local authority required Related experience and knowledge in Quality Management System, including but not limited to recalls, correction and labeling requirements is advantageous. Experience in Good Distribution Practice for Medical Devices (GDPMDS) requirements and ISO13485 is advantageous. At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life. #LI-SA1 #LI-Hybrid Beware of scams online or from individuals claiming to represent Convatec A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at . Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.