Clinical Affairs Manager- Ultrasound

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.

Apply now for the position of Clinical Affairs Manager, and you will join the Ultrasound Regulatory and Clinical Affairs organization at Siemens Healthineers. In this role, you will lead clinical affairs strategy and execution across the ultrasound product portfolio, enabling timely global market access and lifecycle support through robust clinical evidence generation.

This role plays a critical part in shaping and implementing a scalable Clinical Framework that enables proactive creation of clinical data through collaboration with internal stakeholders, external partners, and Clinical Research Organizations (CROs), ensuring alignment with global regulatory and post‑market requirements while advancing innovation and patient safety.

This is an onsite position in our Issaquah, WA office.

Your Role

• Be responsible for both people leadership and strategic regulatory and clinical execution
• Provide overall direction and guidance to cross‑functional teams on clinical evaluation, clinical development, and post‑market clinical activities supporting ultrasound systems, transducers, and intracardiac echocardiography (ICE) catheters.
• Plan, execute, and oversee development of clinical deliverables for global regulatory submissions, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF Plans and Reports, SSCPs, and related documentation, ensuring quality, compliance, and timeliness.
• Serve as a key clinical interface with Collaboration and Clinical Science, Regulatory Affairs, R&D, Product Management, Risk Management, Post‑Market Surveillance, and Quality to ensure early and continuous clinical input across the product lifecycle.
• Implement Hoshin Kanri deployment, maintain, and continuous improve of a clinical framework that enables proactive and systematic generation of clinical data for ultrasound products, considering EU MDR, FDA, and other global regulatory expectations, including premarket and post market clinical evidence requirements.
• Support audits and interactions with regulatory authorities and notified bodies (e.g., FDA, TÜV) on clinical topics, as required.
  
  

Your Expertise

• Deep expertise in clinical evaluation, clinical development, and post‑market clinical evidence generation for medical devices particularly under EU MDR, preferably within diagnostic imaging or cardiology.
• Ability to build and operationalize clinical frameworks that scale across product portfolios and geographies.
• Experience in managing CROs and external partners, with a focus on proactive data generation and regulatory readiness.
• Demonstrated leadership capability, with experience managing and mentoring clinical or cross‑functional teams.
• Ability to balance strategic thinking with hands‑on execution in a highly regulated, matrixed environment.
  
  

Required Skills, Education And Experience For This Position

• Advanced degree (MS, PhD, MD, PharmD, or equivalent) in a scientific, clinical, or biomedical discipline; or a bachelor’s degree with significant relevant experience.
• 5 years of experience in Clinical Affairs, Clinical Science, or Clinical Project Management within the medical device industry, imaging and cardiology preferred.
• Experience working in healthcare or clinical environments desired.
• Demonstrated experience supporting EU MDR clinical requirements (e.g., CER, PMCF, SSCP) and regulatory agency and notified body interactions.
• Prior experience leading people or programs in a clinical or regulatory environment.
• Strong project management, risk management, and stakeholder communication skills.
• Excellent written and verbal communication skills, with the ability to influence at various organizational levels.
• Willingness to collaborate globally and adapt to evolving regulatory and business needs.
• Willingness to travel as needed.
  
  

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.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The Base Pay Range For This Position Is

$128,700 - $176,957

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.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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.

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