Senior Staff Clinical Evaluation Specialist (Remote)
$110.1k - $238.4kStryker
Stryker is hiring a Senior Staff Clinical Evaluation Specialist for our Surgical Technologies business unit. This is a remote position within the United States. To align with team collaboration and business operating hours, candidates must reside in the Eastern or Central time zones .
As the Senior Staff Clinical Evaluation Specialist , 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, Clinical Research, Marketing, Reimbursement & Market Access, Quality, and Product Development 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 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.
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 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.
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 surveillance, and market access activities.
- Experience developing scientific publications, conference presentations, and clinical evidence communication strategies.
- Experience managing complex cross-functional projects within the medical device industry.
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
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