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!