Key Responsibilities

 Quality Management System (QMS):

• Enable the implementation and maintenance of an effective QMS that complies with regulatory requirements.
• Enable internal and external audits related..

Skill & Experience

Post-Market Surveillance:

• Establish and enable post-market surveillance processes to monitor and report radiation events other post-market activities.
• Coordinate with relevant departments to implement corrective and preventive actions based issues and findings related to AERB requirements.

 Cross-Functional Collaboration:

• Collaborate with cross-functional teams, including R&D, clinical affairs, Service, manufacturing, and marketing, to ensure alignment with regulatory requirements.
• Provide regulatory input in cross-functional meetings and projects.

 Regulatory Intelligence:

• Monitor changes in the regulatory landscape and provide updates on potential impacts to the organization.
• Proactively identify emerging regulatory issues and recommend strategies for compliance.

 Training and Education:

• Provide training on regulatory requirements and updates to internal stakeholders.
• Stay updated on industry trends and best practices and share this knowledge within the organization.

 Risk Management:

• Work closely with teams to assess and mitigate regulatory risks associated with product development and commercialization.

AERB related activities include but not limited to

• Single point contact for commercial organization on AERB matters. Single point liaison with regulator on all matter related to licensing, inspection activities, resolving customer issues. Provide training and guidance on pre-sales, delivery, and post installation AERB requirements to commercial organization. Establish and execute compliance monitoring process for AERB requirements across commercial organization. Conduct field audits on QA testing activities to monitor and drive compliant execution. Manage compliance activities on procurement permission compliance across radiation emitting devices. Communicate new/ changing regulatory requirements. Drive implementation of new requirements as and when published/communicated by AERB. Enable digitization initiatives on AERB reports as and when planned. Co-ordinate and Collaborate with industry forums and regulators for advocacy matters. Manage BIS inspections related activities for ISO7620 compliance.

Required Qualification

• Nuclear Medicine physicist, RSO Level III qualified per AERB requirements

Technical Experience

• Experience in a regulated industry in QA / RA / Design / Manufacturing / similar functions.
• Prior Experience of managing AERB supplier activities for radiation generating medical imaging devices and cyclotron