Job Details
Stryker
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 is currently seeking a Regulatory Affairs Specialist to join our Robotics Division to be based in Weston, Florida.
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.
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 Regulatory Affairs Specialist, you will work with some supervision to bring new medical devices to market and ensures ongoing compliance for Stryker’s Mako portfolio. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes. You will support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. This role will support the cutting edge of orthopedic robotic surgery, leveraging advanced software and hardware applications to improve patient outcomes.
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.
Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures.
Evaluate proposed products for regulatory classification and jurisdiction.
Assist in the development of regulatory strategy and updates to strategy based upon regulatory changes.
Coordinate and assist in the preparation of submission packages for regulatory agencies.
Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for international market access and sustaining support.
Author FDA submissions, EU technical documentation, and other regulatory documents to obtain approval to bring new or modified products to market.
Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
Stay abreast of regulatory procedures and changes in regulatory climate.
Investigate regulatory history of similar products to assess approval implications.
Conduct research on submission requirements and options.
Assist with review of labeling and marketing literature for compliance with regulatory requirements.
WHAT YOU NEED:
Bachelor’s Degree required. Bachelor's Degree in Engineering or Science Preferred.
0+ years of experience in an FDA regulated industry required, preferably within medical devices.
RAC certification or Advance Degree (Master in Regulatory Affairs) preferred.
Medical device regulatory experience preferred.
General understanding of product development process and design control.
Familiarity with FDA, Europe and international medical device regulations.
Previous experience with Class II/III medical devices preferred.
Previous experience drafting/authoring regulatory submissions for product approval preferred
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 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