Senior Regulatory Affairs Specialist

Siemens Healthineers

. Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business and product development decisions .

Posted 9/17/2026full-timePalo Alto • California • United StatesSenior💰 $115,980 - $159,478 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading regulatory submissions and strategy development for medical devices, particularly in radiation oncology. Proficient in interpreting regulations and collaborating with cross-functional teams to ensure compliance and timely market access.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device ApplicationsGlobal Regulatory StrategyRAC CertificationFDA 510(k) Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationRegulatory Risk AssessmentData InterpretationRegulatory Strategy DevelopmentTechnical DocumentationMarket AuthorizationRegulatory ComplianceSubmission Lead ExperienceComplex Software-Driven DevicesMedical Device License Applications

Soft Skills

Clear CommunicationStakeholder InfluenceIndependent WorkPriority ManagementCollaboration

Tools & Technologies

FDAHealth CanadaEU MDRISO 13485ISO 14971IEC 62304IEC 62366

Certifications & Qualifications

RAC Certification

Industry Keywords

Radiation OncologyMedical Device StandardsRegulatory AgenciesCross-Functional TeamsTechnical Information Translation

About the role

Key responsibilities & impact

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 recommendations supporting product development, change assessments, and market authorization decisions
Support interactions with regulatory agencies and regional partners by preparing briefing materials, submission responses, and positions on regulatory questions
Translate complex technical information into defensible regulatory submissions and strategies to enable timely global market access for radiation oncology products
Independently lead regulatory assessments, develop strategy options, recommend compliant pathways, and advise leadership on regulatory risks and approaches
Partner with Regulatory Affairs, Product Development, Quality, Clinical, and regional regulatory teams

Requirements

What you’ll need

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
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

Benefits

Comp & perks

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