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Staff Regulatory Affairs Specialist
- Posted: 19/02/2025
- Salary: Competitive
- Location: San Diego, California, United States
- Job Type: Permanent/Fixed Term
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
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.
- 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.
Callum Sparkes
Director