Staff Regulatory Affairs Specialist

Opportunity to join a global diagnostics company's Regulatory Affairs team, to be the SME and lead all regulatory activities for one of the organization's most exciting product lines.ResponsibilitiesLead multiple long-term projects, collaborating with management on key issues including regulatory applications, EU-IVDR submissions, and renewals across global markets, ensuring compliance with applicable rules and regulations. Oversee technical documentation and export certificates.Review and approve product labeling for regulatory compliance, including format, content, and registration impacts.Maintain current knowledge of evolving regulations, emerging standards, and scientific issues in relevant geographies. Develop strategies to comply with new regulations and collaborate with subject matter experts.Experience Required6 years' Regulatory Affairs experience within life sciences, with 4 years in the IVD space submitting 510(k)s and/or IVDR technical documentation.Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.Ability and willingness to work onsite in Mira Mesa.

Created: 2025-03-03