We are a healthcare startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Regulatory Specialist should be experienced and thoughtful about the processes necessary for achieving domestic and regulatory approval.
You'll be joining a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team and communicating daily with the product manager. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.
- Coordinate all activities related to domestic and regulatory submission and approval for medical software solutions.
- Drive regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
- Support the product development team in the implementation of regulatory requirements, including preparation and review of design and test documentation.
- Prepare, coordinate, and file regulatory submission documents.
- Perform regulatory assessment of product changes.
- Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
- Prepare, or contribute to the preparation of post-market surveillance plans and evaluate post-market data.
- Ensure regulatory requirements are met for maintenance of products.
- Support internal and external audits.
- Research and evaluate different risk factors regarding business decisions and operations.
- Stay abreast of current and novel developments in the field.
- Comply with company policies and guidelines.
- As part of a new startup with a highly collaborative culture, perform other related duties and "pitch in" where needed.
- Bachelor's degree or higher.
- 5 years of proven regulatory experience with class II or III medical devices, and FDA approval for 510k, de Novo for software as a medical device
- Experience with new product development standards and documentation for software products.
- Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
- Ability to review and provide critical feedback on design documentation.
- Ability to communicate and interact with regulatory agencies and consultants. Excellent English written and verbal skills.
Skills & Abilities
- Energy and enthusiasm consistent with working for a startup.
- Strong technical presentation skills.
- Strong organizational skills; ability to remain organized and productive in fast-paced work environment with competing priorities.
- Work independently, diligently, and efficiently on assigned tasks and projects.
- Collaborate seamlessly with teams.
OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.
Job duties, activities and responsibilities are subject to change by our company.
Job Type: Full-time
- FDA submissions for devices or software: 3 years (Required)
- New York, NY 10006 (Preferred)