Regulatory Affairs Manager jobs in Jefferson, CO

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.

• 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.

• 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

• 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.

• 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.

• Equity - Stock Options
• Incentive Compensation
• And most importantly - You are joining an awesome team!

Compensation - The salary range target for the role described in this job description is $99,000 to $110,00. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.

RapidAI is committed to creating an inclusive and diverse workplace. 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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