Sr. Regulatory Affairs Specialist

We need to output HTML fragment with sections: About the role? The posting includes intro paragraphs about company, mission, etc. We need to decide which sections to include based on content. We must use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should not repeat job title as heading. No Job ID. Remove boilerplate (EEO, legal, scam warnings, etc). Keep substantive info. We need to preserve all substantive info: location (Palo Alto, CA or Austin, TX), role description, responsibilities, required qualifications, preferred qualifications, travel less than 20%, benefits listed, pay range. We should not include sections with placeholder or vague content. So we need sections: About the role (maybe includes mission/intro?), Responsibilities (list of duties), Requirements (maybe required qualifications), Qualifications (maybe preferred?), Skills (maybe not separate), Benefits, Pay. Schedule? Not given explicitly; travel less than 20% could be considered schedule? But schedule is not given; we could omit Schedule section because no explicit schedule info. The instruction: only include a section when posting has real, specific content for it. Travel less than 20% is not schedule but maybe could be under Responsibilities? It's a requirement. Could be under Requirements. We'll not create Schedule. We need to use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive info, not invent or summarize away detail. So we need to include details like: "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." etc. We need to include location: "either Palo Alto, CA or Austin, TX". Also mention hybrid role, travel less than 20%. We need to include benefits list: 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. Pay range: $115,980 - $159,478. We need to include required qualifications bullet list: 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: 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. We also have "What You Will Bring to the RA Submissions Team" and "Required Qualifications" etc. We'll combine. We need to avoid duplication: there is also "Your Role on the RA Submissions Team" bullet list of duties. We'll put those under Responsibilities. We need to ensure we don't include boilerplate like EEO, legal, scam warnings, privacy notice, export control, data privacy, etc. We also need to avoid repeating the company mission intro maybe as About the role? The intro: "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." That's substantive about role and company. Could be placed under About the role. We also have later "Who we are: ..." and "How we work:" which is also substantive about company. Could be included in About the role as well, but we must avoid duplication and boilerplate. That section is not boilerplate; it's about company culture. We can include it. We need to ensure we don't include the "To find out more about Siemens Healthineers businesses, please visit our company page here." That's a link, maybe considered navigation? It's not essential; could be omitted as it's like a call to action. Probably safe to omit. We need to output only HTML fragment, no markdown fences. Let's structure:

  About the role

  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 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.

  But we need to avoid too much prose; but it's okay. Then Responsibilities:

  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.
  Then Requirements (maybe Required Qualifications):

  Requirements

  • 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.
  Then Preferred Qualifications:

  Preferred Qualifications

  • 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.
  Then Benefits:

  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
  Then Pay:

  Pay

  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.

  We should not include Schedule. We need to ensure we didn't include any boilerplate like EEO, legal, scam warnings, privacy notice, export control, data privacy, etc. We omitted those. Check for any leftover: The "Who we are:" and "How we work:" paragraphs we omitted; we could incorporate them into About the role but we already have a decent About the role. Might be okay to omit as not required? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we must keep all substantive info. The "Who we are:" and "How we work:" are substantive about company. If we omit them, we lose info. So we should include them, perhaps in About the role section as additional paragraphs. We need to decide where to place them. Could add another

  after the initial About the role paragraph. Let's incorporate: After the initial paragraph about role, we can add:

  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.

  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 breakthrough