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Key Responsibilities
1. Radiation Safety Officer Responsibilities
Serve as the designated and AERB-approved Radiation Safety Officer for the Bengaluru manufacturing facility. Based on the approval letter, the RSO is expected to perform duties in accordance with the Atomic Energy (Radiation Protection) Rules and related AERB requirements, submit required reports, and promptly report radiation safety events to AERB.
Ensure compliance with applicable Atomic Energy Act requirements, Atomic Energy (Radiation Protection) Rules, AERB Safety Codes, Guides, and associated regulatory requirements.
Submit periodic radiation safety reports and regulatory updates to AERB as required.
Promptly report radiation safety incidents, unusual occurrences, deviations, or regulatory concerns to AERB and company management.
Serve as the primary site contact during radiation safety inspections and regulatory interactions.
Maintain radiation safety documentation, monitoring records, personnel dosimetry records, training records, and licensing documentation.
Support implementation and maintenance of an effective radiation protection program across the site.
2. AERB Licensing and Regulatory Compliance
Manage AERB licenses, registrations, approvals, permits, and authorizations required for the Bengaluru manufacturing facility.
Support facility registration, license renewals, amendments, modifications, and expansion activities.
Prepare and submit regulatory applications, technical dossiers, responses to deficiency letters, and supporting documentation.
Monitor and assess regulatory changes and determine potential impacts to business operations.
Establish and maintain a productive working relationship with AERB.
Coordinate and manage AERB inspections, audits, and post-inspection commitments.
Ensure timely regulatory reporting and maintenance of all required approvals.
3. Radiation Safety Import and Export Licensing
Manage and support AERB import licensing activities related to radiation-emitting products, components, accessories, sources, and associated equipment.
Coordinate with Supply Chain, Manufacturing, Logistics, Service, and Regulatory Affairs teams to ensure regulatory approvals are obtained prior to shipment.
Review imports and exports for compliance with applicable AERB requirements.
Support import permit applications, amendments, renewals, and related regulatory submissions.
Maintain records of imports, exports, transfers, inventory, and disposition of regulated items.
4. Manufacturing and Facility Support
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.
5. Radiation Worker Protection Program
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.
6. Radiation Safety Training
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.
7. Inspections, Audits and Continuous Improvement
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.
8. Emergency Preparedness and Incident Response
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.
9. Medical Device Regulatory Support (Preferred)
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.
Required Qualifications
Master's Degree in Medical Physics, Radiation Physics, Radiological Physics, Nuclear Physics, or equivalent recognized qualification.
Current AERB-approved Radiation Safety Officer certification or eligibility to be approved as an RSO by AERB.
Minimum 5 years of relevant experience in radiation safety, medical physics, radiation regulatory affairs, or related disciplines.
Demonstrated experience working with AERB regulations and licensing processes.
Strong understanding of radiation protection principles, radiation monitoring, dosimetry, and radiation-generating equipment.
Experience supporting manufacturing, healthcare, medical device, radiotherapy, or industrial radiation environments.
Strong communication, interpersonal, and stakeholder management skills.
Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Healthineers’ specific businesses, please visit our company page here.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. As an equal opportunity employer, we welcome applications from individuals with disabilities.
Skills Required
- Master's degree in Medical Physics, Radiation Physics, Radiological Physics, Nuclear Physics, or an equivalent recognized qualification
- Current AERB-approved Radiation Safety Officer certification or eligibility for AERB RSO approval
- At least 5 years of relevant experience in radiation safety, medical physics, radiation regulatory affairs, or related disciplines
- Experience working with AERB regulations and licensing processes
- Strong understanding of radiation protection, radiation monitoring, dosimetry, and radiation-generating equipment
- Experience supporting manufacturing, healthcare, medical device, radiotherapy, or industrial radiation environments
- Strong communication, interpersonal, and stakeholder management skills
- Experience supporting CDSCO, Medical Device Rules 2017, device registration, manufacturing licenses, and related regulatory activities
Siemens Healthineers Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Siemens Healthineers and has not been reviewed or approved by Siemens Healthineers.
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Leave & Time Off Breadth — Paid time off is presented as notably generous, with a starting allotment around four weeks plus multiple holidays and the potential to grow with tenure. Time-off availability is repeatedly framed as a meaningful part of the overall rewards value.
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Retirement Support — Retirement benefits are positioned as a strong component of total rewards, highlighted by a company match that is described as substantial. This retirement support is repeatedly grouped with other core benefits as a reason overall rewards feel competitive.
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Healthcare Strength — Health coverage is described as robust, spanning medical, dental, and vision options with meaningful employer subsidy for full-time eligibility. Access to accounts like HSA/FSA is also emphasized as part of the healthcare offering.
Siemens Healthineers Insights
What We Do
Siemens Healthineers is a leading medtech company with over 125 years of experience. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. With our strengths in patient twinning, precision therapy, as well as digital, data, and artificial intelligence (AI), we are well positioned to take on the biggest challenges in healthcare. We will continue to build on these strengths to help fight the world’s most threatening diseases, improving the quality of outcomes, and enabling access to care. We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world.
