Radiation Oncology Regulatory Lead – Hybrid

Regulatory Toolkit; Palo Alto (CA); Hybrid; USD 116,000 - 159,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Senior Regulatory Affairs Specialist to develop and execute regulatory strategies for radiation oncology products. The role involves leading submissions, cross-functional coordination, and advising leadership on regulatory risks.

The position offers international collaboration across regulatory teams, advanced devices in a fast-paced environment, and travel less than 20% to support global submissions and market access.

Qualifications

• 7+ years of related regulatory affairs experience.
• Primary regulatory author or submission lead for medical device applications, including FDA 510(k), IDE, Q-submissions.
• Strong ability to interpret regulations, identify data needs, resolve regulatory issues, and collaborate with partners.
• Able to work independently, communicate clearly, and manage competing priorities in a fast-paced environment.
• Willingness to travel less than 20% based on project needs.

Responsibilities

• Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business decisions.
• Lead preparation and execution of regulatory submissions, including strategy development, content planning, timeline alignment, and coordination of inputs.
• Identify regulatory risks, evaluate pathway options, and develop clear recommendations that support product development and market authorization.
• Support interactions with regulatory agencies and regional partners by preparing briefing materials and responses.
• Help enable timely global market access for radiation oncology products by translating complex information into defensible regulatory submissions and strategies.

Skills

Regulatory judgment

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Travel <20%

Education

Bachelor’s degree in engineering, scientific, clinical, or regulatory discipline

Equivalent experience with non-technical degrees

Tools

FDA 510(k)

IDE

Q-submissions

Health Canada MDR

EU MDR CE marking

Job description

Varian Medical Systems, a Siemens Healthineers company, is seeking a Senior Regulatory Affairs Specialist to develop and execute regulatory strategies for radiation oncology products. The role involves leading submissions, cross-functional coordination, and advising leadership on regulatory risks.

The position offers international collaboration across regulatory teams, advanced devices in a fast-paced environment, and travel less than 20% to support global submissions and market access.