Staff Regulatory Affairs Specialist (Remote) - New Product Development

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 Stryker Neurovascular 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:

• 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 support Stryker’s Neurovascular Intracranial Atherosclerotic Disease (ICAD) franchise new products development. You will be responsible to prepare complex submission to gain approvals for clinical studies and commercial distribution in the United States, Europe, and Canada. You will participate on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews testing protocols and reports, labeling and marketing materials, and evaluates proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

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

• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

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

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

• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Evaluates proposed products for regulatory classification and jurisdiction

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

• Negotiates with regulatory authorities throughout the product lifecycle

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Assists other departments in the development of SOPs to ensure regulatory compliance

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

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

• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

• Provides regulatory information and guidance for proposed product claims/labeling

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

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

• Communicates 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) in Engineering, Science or equivalent focus is required.

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

• 3+ years of Medical Device Regulatory Affairs experience required.

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

• Thorough understanding of FDA and international medical device regulations.

• General understanding of product development process and design control.

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

• Previous experience with Class II/III medical devices required

• Previous experience drafting regulatory submissions to FDA required

• Experience interacting with regulatory agencies required

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

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/