Regulatory Project Manager
San Francisco Bay Area, CA
SUMMARY:
An innovative new client of ours in the Digital Health space is anticipating a significant period of growth in 2021, following a recent FDA approval. This exciting biotech works with screening products for severe, genetic diseases. They are looking to begin their growth by adding a seasoned Regulatory Project Manager onboard, who will be a part of an established and collaborative Regulatory team.
RESPONSIBILITIES:
In this role you will be responsible for:
- Understanding regulatory framework and keeping up to date on US and Ex-US HAs, for medical devices and SaMD
- Submission delivery status for relevant submissions and dossiers
- Creating high quality, compliant regulatory documents
- Collaborating with senior team members, supporting other regulatory functions where necessary
- Other general duties as assigned, in conjunction with Regulatory Project Management title
REQUIREMENTS:
The client requires that all candidates have:
- BS or higher in a scientific discipline
- 5+ years' experience in regulatory/project management
- At least 2 years' experience in Medical Devices
- Digital Health experience a plus
- Understanding of FDA/EU submissions process
- Strong collaborative skills
If this sounds like you, please don't hesitate to apply!
