Radiological Safety Officer (RSO)

Posted Yesterday
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2 Locations
Remote
Senior level
Healthtech • Biotech
The Role
Serves as the AERB-approved Radiation Safety Officer for a medical device manufacturing facility. Manages radiation protection programs, personnel dosimetry, training, licensing, regulatory submissions, inspections, incident response, and compliance reporting. Provides radiation safety oversight for manufacturing, testing, validation, facility changes, imports, and exports. Supports CAPA, audits, emergency preparedness, and medical device regulatory activities involving AERB, CDSCO, and MDR 2017.
Summary Generated by Built In

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Analyzes the requirements and prepares product related regulatory submissions.

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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.

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees.  These scammers may attempt to collect your confidential personal or financial information.  If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

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
  • Minimum 5 years of relevant experience in radiation safety, medical physics, radiation regulatory affairs, or related disciplines
  • Demonstrated experience with AERB regulations and licensing processes
  • Strong understanding of radiation protection, radiation monitoring, dosimetry, and radiation-generating equipment
  • Experience in manufacturing, healthcare, medical device, radiotherapy, or industrial radiation environments
  • Strong communication, interpersonal, and stakeholder management skills
  • Experience supporting CDSCO, Medical Device Rules 2017, device registrations, manufacturing licenses, or related medical device regulatory activities

Varian Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Varian and has not been reviewed or approved by Varian.

  • Healthcare Strength Health coverage is described as comprehensive with multiple U.S. medical plan options, virtual care, and targeted support programs for complex needs. Feedback suggests this breadth contributes meaningfully to overall benefits satisfaction.
  • Retirement Support A 401(k) savings plan with company contributions and a defined vesting schedule is part of the package. Investment guidance and a brokerage window reinforce long‑term financial planning support.
  • Flexible Benefits A global framework with Varian‑specific country overviews and site‑dependent perks indicates adaptable offerings by location. U.S. materials highlight choice among HRA/HSA designs and regional HMOs where available.

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The Company
HQ: Palo Alto, CA
10,000 Employees

What We Do

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight.

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