Radiological Safety Officer (RSO)

Provide radiation safety oversight for Halcyon manufacturing, assembly, integration, testing, validation, and acceptance activities.

Evaluate facility changes, engineering modifications, and process changes from a radiation safety perspective.

Participate in risk assessments and implementation of radiation protection controls.

Support commissioning, qualification, and validation activities involving radiation-generating equipment.

Review and approve radiation safety aspects of site procedures, work instructions, and operational controls.

Support future manufacturing expansion projects and facility readiness activities.

Manage and maintain the site's Personnel Monitoring Program.

Ensure all radiation workers receive appropriate monitoring , training, qualification, and authorization.

Review occupational exposure results and investigate any abnormal exposures.

Maintain exposure records in accordance with regulatory requirements.

Implement and promote ALARA (As Low As Reasonably Achievable) principles.

Coordinate with approved dosimetry providers and maintain compliance with personnel monitoring requirements.

Develop, implement, and maintain site radiation safety training programs.

Ensure all relevant personnel receive initial and periodic refresher radiation safety training.

Conduct awareness programs and training for radiation workers and other impacted functions.

Maintain training records and competency documentation.

Provide regulatory and radiation safety guidance to cross-functional teams.

Lead preparedness activities for AERB inspections, customer audits, internal audits, and regulatory assessments.

Support Quality Management System requirements associated with radiation safety activities.

Identify compliance gaps and drive corrective and preventive actions (CAPA).

Monitor compliance metrics and support continuous improvement initiatives.

Participate in management reviews and compliance governance forums.

Support development and maintenance of radiation emergency response plans.

Participate in emergency drills, investigations, and response activities.

Provide technical expertise during radiation-related incidents.

Ensure appropriate notification , reporting, investigation, and corrective actions are completed.

Support Regulatory Affairs activities related to the Central Drugs Standard Control Organization (CDSCO), Medical Device Rules (MDR) 2017, and associated guidance documents.

Provide support for device registration, manufacturing license applications, license amendments, renewals, and post-approval regulatory activities where radiation safety expertise is required .

Coordinate with Regulatory Affairs colleagues to support inspections, audits, and regulatory submissions involving radiation-emitting medical devices.

Monitor and assess regulatory developments related to CDSCO and provide input regarding potential impacts on manufacturing operations and product compliance.

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