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 two years of previous experience providing the knowledge, skills, and abilities necessary to perform the job, or an equivalency consisting of a combination of appropriate education, training, and/or directly related experience. Strong knowledge of medical terminology, solid knowledge of procedural documents, and working knowledge of global safety reporting requirements, including FDA regulations and guidelines are required.
As a Safety Reporting Specialist, the individual will be responsible for receiving, preparing, and submitting safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation, assisting in producing metrics and alerting management to any quality or timeline issues, participating on project teams and potentially leading projects of small to moderate scope, providing training and support to other team members, performing administrative tasks such as filing and maintaining safety reporting systems, liaising with various departments on safety reporting tasks, participating in audits and performing testing activities as needed, and sharing ideas and suggestions with team members to ensure effective communication and participate in process improvement initiatives.
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.