Regulatory Affairs Manager

• 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 

• Review and manage the development, writing, implementation and maintenance of appropriate procedures, templates, metrics, and databases related to regulatory activities and documentation in compliance with the local regulatory requirements 

• Interact with local health authorities during review process to ensure timely regulatory approval 

• Ensure compliance with product post marketing approval conditions 

• Manage product lifecycle maintenance such as product license renewal, listings, change control notifications, etc. 

• Complete all training as required and maintain training plans, records, etc. 

• Review product labeling for approval in advertising and promotional request, field communications, etc. in accordance with ConvaTec standards and procedures as well as the local regulations 

• Support and/or participate as necessary in quality compliance audits 

• Maintain the organization and security for all regulatory paper and electronic files 

• Provide support in product safety issues and product associated events and responsible for reporting to the local health authorities 

• As appropriate, 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 

• Prepare and submit all reporting activities associated with a removal or correction with the local health authorities and ConvaTec Global Compliance Team 

• Maintain timely updates of new product listing, 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 

• Work in close collaboration with key functions such as supply chain, marketing and country business unit managers for regulatory project / change implementation 

• May be tasked to act as the company focal point for interaction with various government agencies in response to queries from the agencies 

• Bachelor/master's degree in science, Medical Technology or related disciplines. Regulatory Affairs Certification (RAC) is preferred.

• Minimum 5 years of experience in medical device regulatory affairs is necessary 

• 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 

• Industry memberships / Professional Registrations 

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