The Regulatory Affairs Manager is responsible for acting as the regulatory representative on developmental core teams culminating in the preparation of relevant regulatory filings to FDA and other international registrations/submissions.
- Participate on product design teams
- Create, evaluate, and update Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Review labeling/promotional/advertising materials, and other documents to ensure compliance with applicable regulations
- 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.