Senior Regulatory Affairs Specialist

Siemens Healthineers

. Partner closely with cross-functional teams to develop and execute regulatory strategies for Radiation Oncology products .

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 extensive experience in regulatory affairs, particularly in leading submissions and strategies for Radiation Oncology products. Proficient in navigating complex regulatory environments and ensuring compliance with global standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA 510(k) SubmissionsEU MDR Technical DocumentationRAC CertificationRegulatory Strategy Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationRegulatory Risk AssessmentData InterpretationRegulatory ComplianceMedical Device Applications

Soft Skills

Clear CommunicationIndependent WorkCollaborationPriority Management

Tools & Technologies

Regulatory Agency InteractionBriefing Material PreparationSubmission Response Development

Certifications & Qualifications

RAC Certification

Industry Keywords

Radiation OncologyISO 13485ISO 14971IEC 62304IEC 62366

About the role

Key responsibilities & impact

Partner closely with cross-functional teams to develop and execute regulatory strategies for Radiation Oncology products
Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications
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
Independently lead regulatory assessments, develop strategy options, recommend compliant pathways, and advise leadership on regulatory risks and approaches
Help ensure products are developed, manufactured, registered, and distributed in compliance with applicable global requirements

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
Demonstrated experience as the primary regulatory author or submission lead for medical device applications
Experience with 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 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 FDA, Health Canada, EU MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and applicable electrical safety standards
RAC certification or demonstrated commitment to continued regulatory professional development (preferred)

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
Hybrid work arrangement