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RapidAI
Denver, CO, United States
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 hosp
Job Source: RapidAIRapidAI
Golden, CO, United States
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 hosp
Job Source: RapidAIEurofins Agro NL
, CO, United States
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent ma
Job Source: Eurofins Agro NLConfidential
Denver, CO, United States
Vice President Regulatory Affairs About the Company Globally recognized telecommunications & technology company Industry Telecommunications Type Public Company Founded 1865 Employees 10,001+ Categories Information Technology & Services Networking Technology Telecommunications Hardware Telecom Hardware Telephones Wireless Phones Specialties Telec
Job Source: ConfidentialJ&J Family of Companies
Denver
Senior Regulatory Affairs Specialist - 2406193618W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. _Remote work options may be considered on a case-by-case basis and if approved by the Company_ Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices
Job Source: J&J Family of CompaniesProclinical Staffing
Denver, CO, United States
Principal Specialist, Regulatory Affairs - Permanent - Denver, CO Proclinical is seeking a Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area. Primary Responsibilities: In this role, you will lead regulatory strategies fo
Job Source: Proclinical StaffingConfidential
Denver, CO, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Geno
Job Source: ConfidentialConfidential
Denver, CO, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialGolden, CO, United States
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 - 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.
Please review our CPRA policies here .
For more informationon the information we collect about our applicants and how we use it, see our CPRA Privacy Notice here .
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Email Alert for Regulatory Affairs Project Manager jobs in Golden, CO, United States
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