(Remote) Staff Regulatory Affairs Specialist

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one 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; 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.

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.

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

Stryker Neurovascular is seeking to hire a Staff Regulatory Affairs Specialist to be based in Fremont, CA or remotely anywhere in the United States. You will support new product development, advancing Stryker’s Neurovascular Intracranial Atherosclerotic Disease (ICAD) product portfolio.

You will be responsible to prepare complex submission to gain approvals for clinical studies and commercial distribution in the United States, Europe, and Canada.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Why come to Stryker? Dozens of Reasons To Love Stryker

Stryker will offer you a competitive total rewards package, including competitive base salary, performance bonus, and benefits. We also offer other non-financial rewards, and engaging work environment and meaningful career advancement opportunity. Stryker Benefits

WHO WE WANT:

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

• 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.

WHAT YOU WILL DO:

As the Staff Regulatory Affairs Specialist, you will contribute to global regulatory strategy, author regulatory submissions, interact with regulatory agencies/notified bodies, review testing protocols/reports, labeling and marketing materials, and evaluate proposed device changes.

• You will provide regulatory guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

• Ensure clinical and nonclinical data, along with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

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

• Assess acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulation.

• Evaluate proposed products for regulatory classification and jurisdiction.

• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.

WHAT YOU NEED:

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

• 5+ years of experience in an FDA regulated industry - required

• 2+ years of Medical Device Regulatory Affairs experience - required

• Class II/III medical device experience - required

• Experience drafting regulatory submissions to FDA - required

• Experience interacting with reg. agencies- required.

• Thorough understanding of FDA and international medical device regulation.

• General understanding of product development process and design control

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

This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.

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/

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 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