Remote Senior Clinical Evaluation Lead, Medical Devices

Stryker; Oregon; Remote; USD 110.000 - 238.000; Vollzeit

Zusammenfassung

Stryker is seeking a Senior Staff Clinical Evaluation Specialist for its Surgical Technologies unit. This remote US role requires residence in the Eastern or Central time zones to align with team hours.

You will lead clinical evidence strategies, manage evaluation projects, and author clinical evaluations and regulatory submissions. The position also involves mentoring cross-functional teams to improve methodologies and documentation.

Qualifikationen

• MS degree in health, clinical, biological, biomedical, engineering, or related field.
• At least 6 years in clinical/regulatory/quality/medical writing or related medical device functions.
• At least 2 years authoring clinical evaluations for medical devices.
• Experience with literature reviews, evidence synthesis and data analysis.
• Experience supporting regulatory submissions and lifecycle activities.
• Fluency in English.

Aufgaben

• Lead the development and execution of clinical evidence strategies for new product development and lifecycle management.
• Manage clinical evaluation projects ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization objectives.
• Author and maintain clinical evaluations, post-market reports, safety and performance summaries, regulatory submissions, annual reports, and other clinical documentation.
• Design and execute systematic literature reviews and synthesize data into conclusions.
• Assess benefit-risk profiles and develop evidence-based regulatory considerations.
• Partner with regulatory authorities and internal stakeholders to address evidence requirements.
• Develop scientific communications including manuscripts, abstracts, presentations and customer-facing materials.
• Mentor team members and lead cross-functional review processes to improve methodologies and efficiency.

Ausbildung

Master of Science in health/science/engineering

Jobbeschreibung

Stryker is seeking a Senior Staff Clinical Evaluation Specialist for its Surgical Technologies unit. This remote US role requires residence in the Eastern or Central time zones to align with team hours.

You will lead clinical evidence strategies, manage evaluation projects, and author clinical evaluations and regulatory submissions. The position also involves mentoring cross-functional teams to improve methodologies and documentation.