Stryker
Overview
Join Strykers Neurovascular Division in Fremont, CA as a Regulatory Affairs Specialist. At Stryker, were driven by a mission to Make Stroke History. Our Neurovascular division advances minimally invasive stroke therapies through Complete Stroke Care solutions, including products for ischemic and hemorrhagic stroke such as stent retrievers, detachable coils, stents, balloons, guidewires, and microcatheters. As part of our team, youll support regulatory strategies that help bring life-saving technologies to patients and empower physicians to deliver better outcomes. 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 per 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 bachelors 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). 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. Compensation and Benefits
Salary range: 69,100.00 to 139,600.00 plus bonus eligibility and benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include medical and prescription drug insurance, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include HSA, FSAs, 401(k), Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers products and services across MedSurg, Neurotechnology, Orthopaedics and Spine, impacting more than 150 million patients annually. Some roles may require vaccinations as an essential function of the job. Other
Seniority level: Associate Employment type: Full-time Job function: Legal Industries: Appliances, Electrical and Electronics Manufacturing; Industrial Machinery Manufacturing; Medical Equipment Manufacturing
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Join Strykers Neurovascular Division in Fremont, CA as a Regulatory Affairs Specialist. At Stryker, were driven by a mission to Make Stroke History. Our Neurovascular division advances minimally invasive stroke therapies through Complete Stroke Care solutions, including products for ischemic and hemorrhagic stroke such as stent retrievers, detachable coils, stents, balloons, guidewires, and microcatheters. As part of our team, youll support regulatory strategies that help bring life-saving technologies to patients and empower physicians to deliver better outcomes. 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 per 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 bachelors 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). 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. Compensation and Benefits
Salary range: 69,100.00 to 139,600.00 plus bonus eligibility and benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include medical and prescription drug insurance, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include HSA, FSAs, 401(k), Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers products and services across MedSurg, Neurotechnology, Orthopaedics and Spine, impacting more than 150 million patients annually. Some roles may require vaccinations as an essential function of the job. Other
Seniority level: Associate Employment type: Full-time Job function: Legal Industries: Appliances, Electrical and Electronics Manufacturing; Industrial Machinery Manufacturing; Medical Equipment Manufacturing
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