Write, coordinate, compile, and submit regulatory documents
The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities
Job Summary
The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Matching Summary
The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
Skills & Requirements
Must-have
Define and implement regulatory strategy
Provide regulatory guidance and support
Write, coordinate, compile, and submit regulatory documents
Engage regulators in oral and written communications
Serve as RA subject matter expert
Review and approve labeling and promotional materials
Nice-to-have
Develop solutions for tough challenges
Make the world healthier, cleaner and safer
Innovative, forward-thinking organization
Exciting company culture
Key Requirements
Bachelor’s degree in life sciences, bio-engineering or related science required
2+ years of experience in Animal Health Diagnostic or Human IVD Regulatory Affairs
Experience working with USDA regulations required
Demonstrated ability to maintain regulatory permits and licenses
Proficiency in preparing regulatory compliance reports