Remote Senior Clinical Evaluation Strategist

Stryker Group; Portage (MI); Remote; USD 110,000 - 238,000; Full time

Job summary

Stryker is hiring a Senior Staff Clinical Evaluation Specialist for the Surgical Technologies unit. This is a remote position within the United States, with candidates expected to reside in the Eastern or Central time zones to align with team hours.

You will lead clinical evidence strategies, manage evaluation projects, author reports, and collaborate with Regulatory Affairs, Clinical Research, Marketing, and Quality teams to ensure evidence informs lifecycle decisions.

Qualifications

• Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field.
• Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related medical device functions.
• Minimum 2 years of experience authoring clinical evaluations for medical devices.
• Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and technical data.
• Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry.
• Fluency in English.

Responsibilities

• Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities.
• Manage clinical evaluation projects, ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization objectives.
• Author and maintain clinical evaluations, post-market clinical follow-up reports, safety and performance summaries, regulatory submissions, annual reports, and other clinical documentation.
• Design and execute systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions.
• Assess benefit-risk profiles of medical devices and develop evidence-based recommendations in accordance with global regulatory requirements.
• Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions.
• Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials.
• Mentor team members, lead cross-functional review processes, and identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency.

Skills

Fluent English

Education

Master of Science

Job description

Stryker is hiring a Senior Staff Clinical Evaluation Specialist for the Surgical Technologies unit. This is a remote position within the United States, with candidates expected to reside in the Eastern or Central time zones to align with team hours.

You will lead clinical evidence strategies, manage evaluation projects, author reports, and collaborate with Regulatory Affairs, Clinical Research, Marketing, and Quality teams to ensure evidence informs lifecycle decisions.