Sr. Regulatory Affairs Specialist

About the role

Varian Medical Systems, a Siemens Healthineers company, is hiring a Senior Regulatory Affairs Specialist in Palo Alto, CA or Austin, TX. The role is a senior individual contributor on the Regulatory Affairs (RA) Submissions Team, partnering closely with cross‑functional teams to develop and execute regulatory strategies for Radiation Oncology products. It requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving global regulatory requirements into clear, actionable guidance. The position provides high visibility across Regulatory Affairs, Product Development, Quality, Clinical, and regional regulatory teams, with opportunities to influence global submission strategy for complex radiation oncology technologies. Travel is expected to be less than 20%.

Responsibilities

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

Required Qualifications

• Bachelor’s degree in engineering, scientific, clinical, or regulatory discipline with 7+ years of related regulatory affairs experience, or equivalent education and experience.
• Non‑technical degrees with equivalent complex medical device experience are acceptable.
• Demonstrated experience as the primary regulatory author or submission lead for medical device applications, including FDA 510(k), IDE, Q‑submissions, Health Canada Medical Device License applications, and EU MDR technical documentation/CE marking.
• Strong ability to interpret regulations, identify data needs, resolve regulatory issues, and collaborate effectively with technical and cross‑functional partners.
• Ability to work independently, communicate clearly, and manage competing priorities in a fast‑paced, ambiguous environment.
• Ability to travel less than 20%, based on project and business needs.

Preferred Qualifications

• Regulatory strategy experience, technical depth in complex medical technologies, and the ability to influence stakeholders through clear, defensible regulatory positions.
• Advanced degree or equivalent depth of technical regulatory experience in a scientific, clinical, engineering, or regulatory discipline.
• Experience leading global regulatory strategy and submissions for radiation oncology systems, complex software‑driven devices, or other highly technical medical technologies.
• Strong working knowledge of global medical device requirements and standards, including FDA, Health Canada, EU MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and applicable electrical safety standards.
• Demonstrated ability to influence stakeholders, advise leadership, respond to regulatory authority questions, and translate complex technical information into clear regulatory positions.
• RAC certification or demonstrated commitment to continued regulatory professional development.

Pay

Base Pay Range: $115,980 – $159,478. Factors that may affect starting pay within this range include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long‑term and short‑term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time