Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.
Position Summary:
The Regulatory Affairs Specialist II provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions. This individual will represent Stereotaxis Regulatory with international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards.
Essential Responsibilities:
•Evaluates potential global regulatory pathways for US, EU, and international product launches/ product enhancements as an active member of Product Development team(s).
•Prepares global regulatory submissions to regulatory authorities, including the FDA, EU Notified Bodies, and other regulatory authorities.
•Interacts directly with regulatory agencies on products / projects at reviewer level.
•Provide regulatory guidance to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
•Review technical documentation, i.e. test reports, test protocols, etc., for completeness and compliance with regulatory standards. Review includes using scientific judgement to guide the teams in understanding how to close any gaps that exist.
•Timely compile materials for license renewals, updates, and registrations.
•Review company marketing literature for compliance with applicable regulations.
•Maintain a thorough knowledge of current QSR and ISO requirements as they apply.
Qualifications & Skills:
•B.S. Degree in a Science or Engineering field highly preferred and/ or business experience.
•3-5 years’ experience in regulated medical device industry highly preferred.
•Knowledge of global Class I, II and/or III hardware/software/sterile medical device requirements.
•Extensive knowledge of global quality system requirements preferred.
•RAC Certification preferred.
•Ability to communicate effectively required
•Ability to interpret domestic and international regulations as they apply to company activities.
•Demonstrated project management skills to plan, conduct and implement system assessments
•Legally authorized to work in the United States.
Work Conditions:
This role is an in-office position at our Rogers, MN facility.
Culture:
Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.
Date Needed By
Hiring Manager
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