Senior Regulatory Compliance Professional

2 days ago

Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 1,20,00,000 - ₹ 1,80,00,000
Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring the compliance of medical devices with regulatory frameworks. Your responsibilities will span across various aspects of device development and post-market surveillance.

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  • Develop and maintain technical documentation and declarations of conformity for medical devices.
  • Oversee and manage post-market surveillance and vigilance reporting to ensure timely identification and resolution of any potential issues.
  • Act as the primary liaison with regulatory bodies on submissions, feedback, and incident notifications, fostering strong relationships and facilitating seamless communication.
  • Manage device labeling, advertising claims, and technical content for compliance, ensuring that all promotional materials accurately reflect the features and benefits of our products.
  • Drive regulatory strategy across EU MDR, UK MDR, and US FDA frameworks, staying abreast of evolving regulatory requirements and adapting our approach accordingly.
  • Maintain compliance with international standards and their applicability, conducting thorough risk assessments and implementing measures to mitigate any potential risks.
  • Own the effectiveness of internal and external quality processes, identifying areas for improvement and implementing corrective actions to ensure ongoing excellence.
  • Lead clinical evaluation and post-market surveillance activities, leveraging your expertise to inform strategic decisions and drive business growth.
  • Support SDLC process compliance in collaboration with product and tech teams, ensuring that our development processes are aligned with regulatory expectations.
  • Implement and manage QMS, including audits (internal/external), CAPA processes, and non-conformances, maintaining a culture of continuous improvement and accountability.
  • Conduct company-wide training on regulatory procedures and track compliance coverage, empowering employees with the knowledge and skills necessary to meet regulatory requirements.
  • Coordinate with external medical devices and allied consultants, notified bodies, and global teams, cultivating a network of experts and resources to support our regulatory endeavors.
  • Establish dashboards and reporting metrics for senior management, providing actionable insights and facilitating data-driven decision making.

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