Senior Regulatory Affairs Specialist (Remote) (R451558)
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
We are currently seeking a Senior Regulatory Specialist to join our Joint Replacement Regulatory Affairs Market Access Division to be based in Weston, FL or remotely anywhere within the United States.
WHO WE WANT:
Self-directed initiators. 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 Senior Regulatory Affairs Specialist, you will support Stryker’s Joint Replacement sensor-assisted orthopedic technology portfolio facility and product registration for both US and OUS Global Regulatory release (change in legal manufacturer and manufacturing site transfer). You will coordinate submission preparation activities for routine and major submissions to regulatory agencies. Coordinates, schedules, prepares and compiles documents containing scientific information for submission to regulatory agencies, for review and sign-off by line management. Reviews regulatory submissions and sequencing documents for quality and internal and regulatory compliance. Tracking information associated with submissions. Coordinates and tracks preparation of sections of submission documents and dossier sections.
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 changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
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:
Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
3+ years of experience in an FDA regulated industry required, preferably within medical devices.
A minimum of 1 year 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 preferred.
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.
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