In this role, the Regulatory Affairs Specialist will serve as the core team contact for various Warning Letter Remediation Teams, provide guidance and regulatory strategy for changes, document change assessments within the PLM system (Agile), and write Regulatory submissions as needed to support project teams.
1. Preparing comprehensive regulatory strategies for Warning Letter remediation activities relative to process/product improvements. Clearly communicates requirements and strategies to project teams and RA management.
2. Preparing US, EU, and/or Canada submissions as required by projects.
3. Providing accurate and consistent regulatory recommendations, decisions, and feedback to project teams.
4. Following Spectranetics Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD, PMDA, CMDR and all other applicable regulations.