Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification, and at least 2+ years of relevant experience. Previous experience providing the knowledge, skills, and abilities necessary to perform the job is preferred. Familiarity with local regulatory guidelines and submission processes is beneficial.
As a Country Approval Specialist, you will prepare, review, and coordinate local regulatory submissions (MoH, EC, etc.) in alignment with global strategy. You will provide local regulatory strategy advice, coordinate site start-up activities, work with investigators, and ensure accurate trial status information is entered into databases. Additionally, you may develop patient information sheets, assist with grant budgets, and maintain country study files, all while adhering to PPD SOPs and client directives.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.