- Fremont, CA, 94536, US
- Remote, United States, US
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Why join Stryker?
Job description
Stryker is hiring a Senior Staff Medical Writer for our Neurovascular Division. This is a remote position within the United States.
As the Senior Staff Medical Writer, you will lead the development of clinical evidence strategies and scientific documentation that support regulatory submissions, market access initiatives, and product lifecycle decisions. This position partners closely with Regulatory Affairs, Research and Development, Clinical, Marketing, and Quality teams to ensure clinical evidence is effectively evaluated, communicated, and applied throughout the product lifecycle.
What You Will Do
- 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 documentation, 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.
What You Need
Required
- 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 field.
- Minimum 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.
Preferred
- 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.
Posted Date: 11/04/2026 This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- USN: $110,100 - $183,400 USD Annual
- US5: $115,600 - $192,600 USD Annual
- US10: $121,100 - $201,700 USD Annual
- US15: $126,600 - $210,900 USD Annual
- US20: $132,100 - $220,100 USD Annual
- US30: $143,100 - $238,400 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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