Regulatory Manager

Role & responsibilities

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.

Preferred candidate profile

• Bachelors 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.