This is a full-time, on-site role for a Regulatory Affairs Executive at TACIT MEDTEK. The Regulatory Affairs Executive will be responsible for:
- Regulatory Documentation: Ensure accurate and complete regulatory documentation.
- Meeting Regulatory Requirements: Stay up-to-date with the latest regulatory requirements.
- Regulatory Compliance: Ensure compliance with regulatory standards and guidelines.
- Dossier Preparation: Prepare comprehensive and well-organized regulatory dossiers.
- Regulatory Affairs Processes: Have a strong understanding of regulatory affairs processes and procedures.
- Handling Queries and Amendments: Manage queries and post-approval amendments.
- Market Intelligence: Provide market intelligence and support ISO 13485 site audits and compliance.
Qualifications
- Regulatory Documentation: Proven ability to ensure accurate and complete regulatory documentation.
- Regulatory Requirements: Knowledge of the latest regulatory requirements.
- Regulatory Compliance: Experience in ensuring compliance with regulatory standards and guidelines.
- Dossier Preparation: Competency in preparing comprehensive and well-organized regulatory dossiers.
- Regulatory Affairs: Strong understanding of regulatory affairs processes and procedures.
Skills
- Regulatory Requirements
- Regulatory Affairs
- Dossier Preparation
- Compliance
- Market Intelligence
- ISO 13485 Audits
- Post-approval Amendments
