Regulatory Affairs Project Manager
RapidAIJob Summary
We are seeking a Regulatory Affairs Project Manager to assemble, distribute, and track information pertinent to the regulatory process. The ideal candidate will have strong writing, communication, and interpersonal skills, as well as knowledge of FDA, EU, and other regulatory body regulations. They will work with development project teams to develop regulatory strategy for new products, evaluate risk of proposed strategies, and review labeling and promotion materials for compliance. This is a full-time or hybrid position that offers flexible remote work options, $4,000/year travel stipends, and equity in a fast-growing company. The successful candidate will have a Bachelor's degree and 2-5 years of experience in the SaMD industry, with Regulatory Affairs Certification preferred.
Position Duties And Responsibilities
- Assemble, distribute, store, track and retrieve information pertinent to the regulatory process, including the regulatory submissions process
- Author and publish electronic submission
- 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
- 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
- This position does not have direct reports.
- Perform any other related activites assigned by reporting manager.
Education, Experience, And Qualification
- Strong writing, 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
- Ability to identify risk in Regulatory strategies
- Strong problem-solving skills
- Bachelor’s degree required
- A minimum of 2-5 years of experience in SaMD or medical device industry
- Regulatory Affairs Certification (US or EU) preferred
