California Licensed Regulatory Affairs Specialist

Job Summary

Supporting post-market regulatory compliance activities, the full-time California Licensed Regulatory Affairs Specialist will manage adverse event reporting, field actions, and recalls for in vitro diagnostic products in a hybrid/remote environment.

Key responsibilities:

• Conduct timely assessments of potential adverse events and field actions to determine regulatory reportability
• Develop and execute regulatory plans for complex projects, including new products and maintenance of existing marketing authorizations
• Provide regulatory guidance and training to cross-functional teams and external partners

Required qualifications:

• Minimum of 5 years of related experience with a Bachelor's degree, or 3 years with a Master's degree, or a PhD without experience
• Experience in Regulatory Affairs, preferably within an in vitro diagnostics device company
• Strong understanding of FDA regulations and familiarity with international requirements (EU, Canada, Australia, Japan, China)
• Demonstrated ability to work independently with complex technologies
• Proficiency in office automation programs and corporate database tools