Senior Regulatory Affairs Specialist

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

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers, based in California, seeks a Senior Regulatory Affairs Specialist to join the RA Submissions Team in Palo Alto, CA or Austin, TX. You will lead cross-functional regulatory discussions and oversee submissions for radiation oncology products.

This role requires strong regulatory judgment, independent execution, and collaboration with product development, quality, clinical, and regional teams to enable timely global market access.

Qualifications

• Bachelor’s degree in engineering, scientific, clinical, or regulatory discipline with 7+ years of related regulatory affairs experience.
• Experience as primary regulatory author or submission lead for FDA 510(k), IDE, Q-submissions, Health Canada Medical Device License, and EU MDR documentation.
• Strong ability to interpret regulations, identify data needs, resolve issues, and collaborate with technical partners.
• Ability to travel less than 20%, based on project and business needs.
• Ability to work independently, communicate clearly, and manage competing priorities in a fast-paced, ambiguous environment.

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 cross-functional inputs.
• Identify regulatory risks, evaluate pathway options, and develop clear recommendations that support product development and market authorization decisions.
• Support interactions with regulatory agencies 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.

Skills

Regulatory judgment

Independent work

Cross-functional collab

Education

Bachelor’s degree in engineering, science, or regulatory

Job description

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.

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.

Your Role on the RA Submissions Team

• 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.

What You Will Bring to the RA Submissions Team

Required Qualifications

You will be successful in this role if you have 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.

Preferred Qualifications That Will Set You Apart

• 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.

This opportunity offers the chance to play a meaningful role in bringing innovative radiation oncology technologies to global markets while partnering with experienced cross-functional teams in a mission-driven healthcare environment. For a regulatory professional who enjoys strategic problem-solving, technical depth, and visible business impact, the Senior Regulatory Affairs Specialist role provides a strong platform for continued growth and contribution.

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.

The base pay range for this position is:

$115,980 - $159,478

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

• 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

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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