Regulatory Affairs Manager/Sr. Manager role
Location: Malvern, PA/ Greater Philly area
A growing biotech company that specializes in developing point-of-care products for the treatment of a variety of debilitating diseases, primarily in the oncology space. This biotech company has secured revenue through the development of an in-vitro diagnostics test for the qualitative detection and determination of IgG and IgM antibodies to the COVID-19 virus. This company is building this department from scratch and is willing to move quickly for the right candidate.
The company prefers organic growth so there is no ceiling for career progression. This is strictly an expansionary hire and is something that will be tailored to the right candidate. This role will report directly to the CEO.
- Looking for someone with 5-7 years' experience in Regulatory
- 510k submission
- Diagnostics/ Point of Care Diagnostic
- Experience in emergency use authorization is not a requirement but recommended
- Prior FDA experience
- Background working in Quality (GMP, batch release, batch records)
