What are the responsibilities and job description for the Staff Regulatory Affairs Specialist position at Catalyst Life Sciences?
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
