Staff Regulatory Affairs Specialist (Remote)

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Why regulatory affairs/quality assurance 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 Regulatory Affairs 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular Division to be based in Fremont, CA or 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.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

What you will do

As the Staff Regulatory Affairs Specialist, you will support Stryker’s Neurovascular Acute Ischemic Stroke (AIS) portfolio new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will advise project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

• Partners regularly with marketing, engineering, clinical and quality on project and product development teams. ​

• Serves as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities. ​

• Develops global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information on FDA clearances/approvals of competitors, and proactively shares this information.

• For new, routine or ongoing issues, communicates with regulatory agencies. Prepares for meetings with regulatory agencies and investigators.

• Mentors others on a regular basis. Is not expected to supervise others.

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

• Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.

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

• Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs 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.

• Understands: Stryker’s systems, biocompatibility requirements, CMDRs, Design Control, Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.

• Uses existing project management tools, and develops/implements new tools as needed.

• Performs responsibilities required by the Quality System and other duties as assigned or requested.

What you need

• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

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

• A minimum of 3 years of Medical Device Regulatory Affairs experience required.

• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

• General understanding of product development process and design control.

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

• Thorough understanding of FDA and international medical device regulations.

• Previous experience with Class II/III medical devices preferred.

• Previous experience drafting regulatory submissions required.

• Experience interacting with regulatory agencies preferred.

• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

• Ability to analyze and resolve non-routine regulatory issues using independent judgment.

• Excellent analytical and writing skills.

• Excellent interpersonal, written and oral communication skills.

• Effective organizational skills.

• Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

#LI-Remote

Our benefits

Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off 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.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/