Staff Regulatory Affairs Specialist (Remote) (R449283)
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
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
We are currently seeking a Staff Regulatory Specialist to join our Joint Replacement Division to be based in Virginia, New Jersey, New York, Pennsylvania, Maryland or Connecticut.
Who we want:
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do:
As the Staff Regulatory Affairs Specialist, you will work with minimal supervision to support Stryker’s Joint Replacement portfolio new product development for both US and OUS Global Regulatory release. You will mentor junior colleagues in the development of their regulatory skills. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing material, and evaluate proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
Evaluates proposed products for regulatory classification and jurisdiction
Evaluate medical device regulations and develop strategies for bringing products to market.
Provide regulatory input and technical guidance on global regulatory requirements to product development teams
Anticipates regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly
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
Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
Assess global impact of changes to launched products and support notifications/submissions as required.
Reviews labeling and marketing literature for compliance with regulatory requirements.
Possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.
Author and update divisional SOPs, recommends timely changes to ensure regulatory compliance, and leads process improvements to maximize efficiencies.
Provide regulatory information and guidance for proposed product claims/labeling
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 interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
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 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, Europe and international medical device regulations.
Previous experience with Class II/III medical devices preferred.
Previous experience drafting 510(k)s preferred.
Experience drafting regulatory submissions for product approval 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.
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.