Clinical Affairs Manager- Ultrasound

Siemens Healthineers

9d•Onsite

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

Experience working in healthcare or clinical environments desired.

Responsibilities

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.