Regulatory Affairs Specialist

Join Stryker’s Neurovascular Division in Fremont, CA as a Regulatory Affairs Specialist. At Stryker, we’re driven by a mission to “Make Stroke History.” Our Neurovascular division is dedicated to advancing minimally invasive stroke therapies through our Complete Stroke Care solutions. We offer innovative products and services for both ischemic and hemorrhagic stroke, including stent retrievers, detachable coils, stents, balloons, guidewires, and microcatheters. As part of our team, you’ll play a critical role in supporting regulatory strategies that help bring life-saving technologies to patients and empower physicians to deliver better outcomes. Stroke remains a leading cause of death—accounting for 1 in 20 deaths according to the CDC—and your work will directly contribute to changing that statistic. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Workplace Flexibility: Candidate must reside within a commutable

distance to Fremont, CA but is expected to be onsite at the facility multiple times/week.

What You Will Do

• Support the Neurovascular product portfolio by assessing design, manufacturing, and labeling changes to ensure regulatory compliance throughout the product lifecycle.
• Advise cross-functional teams on regulatory pathways and requirements for changes to marketed devices in the US, EU, and Canada.
• Develop and update regulatory strategies in response to evolving regulations and product modifications.
• Evaluate regulatory environments and anticipate potential obstacles, proposing proactive solutions.
• Assess preclinical, clinical, and manufacturing changes to determine appropriate regulatory filing strategies or alternatives.
• Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable guidelines and monitor review progress.
• Ensure alignment of clinical and nonclinical data with regulatory requirements to support product claims.
• Communicate effectively with regulatory authorities during submission development and review processes.
  
  

What you need:

Required

• A bachelor’s degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
  
  

Preferred

• Familiarity with FDA-regulated or other highly compliant industries, with a solid understanding of regulatory standards and practices.
• Exposure to Medical Device Regulatory Affairs or Engineering through coursework, internships, or project-based experience.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs).
• Possesses a solid understanding of the product development process and design control principles, with prior experience working with U.S. Class II and Class III medical devices.
• Demonstrates strong analytical and writing skills, effective organizational abilities, and advanced proficiency in Microsoft Office Suite, particularly Excel.
  
  

69,100.00 to 139,600.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine 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.