Sr. Regulatory Affairs Specialist

Siemens Healthineers•Greendale, WI

2d•$115,980 - $159,478•Hybrid

About The Position

Varian Medical Systems, a Siemens Healthineers company, is hiring a Senior Regulatory Affairs Specialist in either Palo Alto, CA or Austin, TX. The Senior Regulatory Affairs Specialist is a senior individual contributor on the RA Submissions Team who partners closely with cross-functional teams to develop and execute regulatory strategies for Radiation Oncology products. The Senior Regulatory Affairs Specialist role requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving global regulatory requirements into clear, actionable guidance. This 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. Under the direction of Regulatory Affairs Management, this role independently leads regulatory assessments, develops strategy options, recommends compliant pathways, and advises leadership on regulatory risks, pathway options, and recommended approaches to support informed decision-making. The position is well-suited for a regulatory professional who brings both execution excellence and sound, defensible decision-making in a fast-paced business environment. This hybrid role combines scientific, technical, regulatory, and business knowledge to help ensure products are developed, manufactured, registered, and distributed in compliance with applicable global requirements. Travel is expected to be less than 20%, based on project and business needs.

Requirements

Demonstrated ownership of medical device submissions, strong regulatory judgment, and the ability to independently manage complex priorities.
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.

Nice To Haves

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.

Responsibilities

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.