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 advantages 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 http www convatecgroup com 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 http www convatecgroup com 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 careers Convatec com 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 Notice to Agency and Search Firm Representatives Convatec is not accepting unsolicited resumes from agencies and or search firms for this job posting Resumes submitted to any Convatec employee by a third party agency and or search firm without a valid written and signed search agreement will become the sole property of Convatec No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral Thank you Already a Convatec employee If you are an active employee at Convatec please do not apply here Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - 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📌 Ra/qa Manager (Haryana)
🏢 Covantec
📍 Haryana