Senior Staff Medical Writer (Remote)

Stryker • Fremont, CA

5d • Remote

About The Position

Stryker is hiring a Senior Staff Medical Writer for its Neurovascular Division. This is a remote position within the United States. The role leads the development of clinical evidence strategies and scientific documentation supporting regulatory submissions, market access initiatives, and product lifecycle decisions. It works closely with Regulatory Affairs, Research and Development, Clinical, Marketing, and Quality teams to ensure clinical evidence is appropriately evaluated, communicated, and applied throughout the product lifecycle.

Requirements

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

Nice To Haves

• Doctoral degree (PhD, PharmD, MD, or equivalent) in a health- or science-related discipline.
• Experience supporting global medical-device regulatory requirements, including clinical evaluation, post-market clinical follow-up, and market access activities.
• Experience applying global regulatory requirements, including ISO, FDA, and international regulations.
• Experience managing complex cross-functional projects within the medical-device industry.

Responsibilities

• Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities.
• Manage clinical evaluation projects, aligning clinical evidence with regulatory strategy, product claims, and commercialization objectives.
• Author and maintain clinical evaluations, post-market clinical follow-up documentation, regulatory submissions, annual reports, and other clinical documentation.
• Design and conduct systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions.
• Assess medical-device benefit-risk profiles 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior