Seattle, United States
$130,000 - $150,000
about 1 month ago
An opportunity to join an innovative Seattle-based biotech who are at the forefront of cutting-edge technology in the booming diagnostics space. Working closely with some of the most respected regulatory professionals in the exciting genomic-aided diagnostics field, you'll be able to build and develop existing skills while simultaneously being a part of commercializing ground-breaking, life saving tech.
- Writing, reviewing, and submitting 510(k)s for IVD products used for cancer diagnosis.
- Cross functional projects, working closely with R&D, operations, and quality in order to achieve company and regulatory goals.
- Creating, evaluating, and updating Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained, or enhanced to streamline the process.
- Providing insightful, and informed decisions on the most likely successful route to gain regulatory clearance.
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Interpret RA policies and guidance and correctly apply them as regulatory activities
- Develop, manage, and execute regulatory plans for projects, including diagnostics, companion diagnostics, research use only, laboratory use reagents, etc.
Experience Required to be Considered
- 5+ years experience in Medical Devices Regulatory Affairs with FDA regulated products, with prior exposure working with diagnostics (IVD, CDx) an advantage in all applications
- BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences.
- Working knowledge of FDA QSR and ISO 13485 regulations, and 510(k), IDE, and/or PMA submissions experience
- Strong organizational skills and ability to support multiple projects
- Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
- Proven ability to work on product development teams
- Intellectual curiosity and an ability to digest complex technical data desired.