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Regulatory Affairs Project Manager - Denver, United States - RapidAI
Description
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions.RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow.
Based on intelligence gained from over 10 million scans in more than 2,000 hospitals in over 60 countries, the Rapid platform transforms care coordination, offering care teams a level of patient visibility never before possible.
RapidAI – where AI meets patient care.At RapidAI, we believe in leveraging cutting-edge technology and research to impact millions of lives.
Our software products enhance doctors' capabilities across hospitals worldwide to respond to and make the best decisions for patients quickly.
We are looking for a high-energy employee who is excited to be at the forefront medical device software development.The successful candidate will meet the criteria defined below, and in doing so, will help deliver the best patient care to patients all around the world.
What you will do:
Assemble, distribute, store, track and retrieve information pertinent to the regulatory process, including the regulatory submissions process
Author and publish electronic submissions
Manage requests from foreign government and/or distributors as needed
Research, analyze and communicate information pertaining to the appropriate regulatory pathway for new or modified products
Provide regulatory direction to development project teams as a core team member; helps develop regulatory strategy for new products
Evaluate risk of proposed regulatory strategies; may offer solutions
Review proposed labeling for compliance with applicable global regulations
Review and evaluate promotion and advertising material for compliance with applicable regulations
Review proposed product changes for impact on regulatory status of the product
Communicate with regulatory and governmental agencies
Labeling and promotion materials review
Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams
Assist quality team – including but not limited to training and document control
Work with external RA partners to maintain and update foreign registrations
This position does not have direct reports.
Perform any other related activities assigned by reporting manager.
What you bring:
Strong written/verbal communication and interpersonal skills
Strong attention to detail; ability to multi-task and balance competing priorities
Knowledge of overall business environment, the SaMD industry, and the marketplace
Ability to learn and stay abreast of regulations pertinent to medical devices
Ability to building relationships between Regulatory Affairs and other areas of the organization: ability to communicate effectively at all levels
Knowledge of FDA, EU, and other regulatory body regulations
What we offer you:
RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
Medical Benefits – We offer a range of policies through TriNet
Life Insurance/AD&D is 1X times your annual salary
We pay 100% for Short and Long Term Disability.
Healthcare and Dependent care flexible spending accounts are available
A 401k plan is offered through Empower
RapidAI provides $100 a month for internet/cell/phone services.
Time Off:
We have 10 company paid holidays
RapidAI has a flexible vacation policy. We urge employees to take vacation Vacation allows employees to renew, reinvigorate, and rejuvenate.
Other Cool Benefits:
Equity - Stock Options
Incentive Compensation
And most importantly - You are joining an awesome team
Compensation
We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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