Senior Regulatory Affairs Specialist

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 Senior Regulatory Affairs Specialist to join our Neurovascular Division to be based in Salt Lake City, Utah.

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.

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• 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.

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

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

What you will do

As a Senior Regulatory Affairs Specialist, you will support Stryker’s Neurovascular product portfolio throughout the product lifecycle by assessing design changes, manufacturing changes and labeling changes made to marketed devices. You will support cross-functional teams by advising teams on regulatory pathways and applicable regulatory requirements for changes to marketed devices. You will ensure regulatory compliance by completing thorough assessments, documenting robust regulatory strategies, and filing the appropriate submissions in the US, EU, and Canada for clearances and / or approvals.

• Evaluate the regulatory environment and provide internal advice throughout the product lifecycle for marketed devices to ensure product compliance.

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

• Assist in the development of regulatory strategies and update strategies based upon regulatory changes.

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

• Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

• Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

• Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

• Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

What you need

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

• A minimum of 3 years of experience in an FDA or highly regulated industry required.

• A minimum of 1 year in Medical Device Regulatory Affairs or Engineering role required.

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

• General understanding of product development process and design control preferred.

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

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/