Job Description

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.

Responsibilities

• Lead 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 Required

• 6 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.

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