Shift Type
Job Title
Regulatory Affairs Specialist II
Education
Bachelor's Degree
Location
Minneapolis, MN 55401 US (Primary)
Career Level
Experienced (Non-Manager)
Category
Regulatory and Compliance
Date Needed By
Job Type
Full-time
Travel
Job Description
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.
Job Requirements
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.
Hiring Manager
Exemption Type
# of Hires Needed
1
Wage Amount
