Senior Regulatory Affairs Specialist

Join Strykers Neurovascular Division in Fremont CA as a Senior Regulatory Affairs Specialist. At Stryker were 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 youll 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 deathaccounting for 1 in 20 deaths according to the CDCand your work will directly contribute to changing that statistic. Watch this video to see how Stryker is making a difference: 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.

• 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

• A bachelors degree (B.S or B.A) required; preferably in Engineering Science or equivalent focus.

• Minimum 3 years of hands-on experience in FDA-regulated or similarly high-compliance industries demonstrating a strong understanding of regulatory standards and practices.

• Minimum of 1 year of experience in Medical Device Regulatory Affairs or Engineering.

Preferred

• 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.