Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you. 

Job Responsibilities:

AERB:

- Pre-market activities such as:

• Identification of regulatory (e.g. RGM - Radiation Generating Machines) requirements prior to sale, transfer, installation, and customer acceptance
• Product registration of radiation generating machines (e.g. NOC, TAC) as well as establishment/facility registration licenses.

- Post-market activities such a vigilance reporting and corresponding communication with the authorities.
- Responsible for ensuring that all reporting requirements are satisfied regarding radiation generating machines, nuclear material, RAM shipments, Waste shipments.

- Maintain applicable local, state, country and regional licensing and registrations allowing VMS to sell, service and install RGMs in India.

- Establish and maintain a successful relationship with the AERB.

- Provide training of internal colleagues as well as Varian customers regarding regulatory requirements in India.

- Provide internal support to colleagues e.g. Sales, Service, Engineering, Product
- Management, Regulatory Affairs allowing earliest possible market clearance by using a risk-based approach and sound decision making.

- Provide external support to Varian customers in India to facilitate their compliance activities (e.g. AERB licenses) related to the Varian products.

- Is responsible and accountable for reporting on regulatory status as well as updating regulatory licenses before they expire.

- Manages regulatory inspections at Varian India related to radiation regulation.

- Manages the dosimeter program in co-operation with specific RSO’s (Radiation Safety Officers) including:

• Keep records of all radiation workers’ exposures.
• Consistently review and investigate all exposures over VMS action levels.

- Manage Radiological Worker Training Program in cooperation with specific RSO’s including:

• Ensure all new hires receive RWT.
• Ensure all radiological workers are properly trained and receive regular refresher training.

- Be available to assist during radiation related emergencies.

Experience & Qualification:

- Master’s Degree in Medical Physics.
- Ideally 1-2 years' experience of radiation regulation India related to radiation emitting machines and nuclear sources.
- Medical device background/experience in related field e.g. Radiation Safety, Regulatory Affairs, Quality Assurance, Service, Installation, Engineering.
- Experience of working and communicating with different regulatory authorities’ requirements (e.g. AERB in India) and corresponding successful relationship management with the regulators.
- Ability, competence, and confidence to interact with people. Must be mature and tactful.
- Effective interpersonal and communication skills.
- Basic knowledge about standards and government regulations applicable to medical devices outside India e.g. ISO 13485, 21 CFR 820 QSR, MDD 93/42/EEC preferred.

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.