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Manager Regulatory Affairs, Medical Dev 

Position Purpose:

The Regulatory Affairs Manager – Medical Devices will be responsible for managing the regulatory strategy and ensuring the compliance of radiology medical devices with applicable regulations. This role involves working closely with internal teams, including global regulatory affairs, commercial, supply chain, quality assurance, legal, etc. to navigate the regulatory approval process for medical devices . The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India and some other South Asia markets. Additionally, the role will involve managing interactions with regulatory agencies, maintaining product documentation, and ensuring ongoing compliance with relevant standards and guidelines.

YOUR TASKS AND RESPONSIBILITIES

• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for India import license applications for Bayer Radiology medical devices.
• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for India as per required timelines to theGlobal Regulatory Affairs teams.
• Review the device labelling materials to ensure the compliance to local labelling requirements.
• Monitor and communicate the new or updated regulations from India, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of India are kept up to date in database systems.
• Support the policy research and shaping activities as required for the India device business.
• Develop and maintain tracking of regulatory device activities, including submission prioritization, submission status tracking and submission dossiers archiving.
• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advices from India regulatory standpoint.
• Work in close collaboration, ensuring alignment and effective communication with APAC Device Regulatory Head, India Commercial and Global Device Regulatory Affairs teams.

WHO YOU ARE:

• PhD / Masters / Graduate in Engineering, Pharmaceutical, Chemistry or Biological Sciences.
• 3-5 years of proven India regulatory experience in pharmaceutical or medical device industry, including hands on India registration experience and direct working experience with CDSCO.
• Familiar with local regulations and regulatory assessment of design changes.
• Experience multitasking in a deadline controlled and highly regulated environment.
• Proven ability to communicate effectively in English both verbally and in writing.
• Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., CDSCO.
• Detail oriented and well-organized.
• Motivated to work independently as well as with cross-functional teams.

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