Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

We are currently seeking a Staff Regulatory Specialist to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere within the United States.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Staff Regulatory Affairs Specialist, you will be responsible for providing leadership, organization and coordination of the Neurovascular APAC regulatory strategies and submissions to support high impact product launches and ongoing market access.

• Prepares complex submissions to gain approvals through interface with NMPA regulators and in-country RA personnel. Drafts and/or reviews China product technical requirement, China Clinical Evaluation Report/Summary, China Biological evaluation report, etc. Ensures that existing approvals and documentation are maintained.

• Develops China regulatory strategies for project teams. Provides input for product development and ensures compliance to NMAP regulations & standards. Monitors, researches and obtains information on NMPA approvals of competitors, and proactively shares this information.

• Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements China regulatory action plans based on the changes. Organizes and maintains RA files.

• Sets up and implements China NMPA consultation plans. Communicates and interfaces directly with NMPA reviewers to present regulatory rationales and negotiate product approvals.

• Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, as needed to support departmental functions and Stryker’s Quality System. Prepares and delivers training programs to the department and other functional groups to ensure compliance.

• Provides guidance to internal product test for NMPA registrations and facilitates communications between local RA and product development teams.

• Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.

• Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage.

What you need

• Bachelor’s Degree (B.S or B.A) required.

• 5+ years of experience in an FDA regulated industry required; preferably with medical devices.

• 3+ years of Medical Device Regulatory Affairs experience required

• Thorough understanding of China NMPA and international medical device regulations.

• General understanding of regulations applicable to the conduct of clinical trials.

• General understanding of product development process and design control.

• Effective written and oral communication, technical writing and editing skills.

• Chinese language fluency highly desired.

$83,000 - $176,800 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com