
Regulatory Compliance Specialist
2 days ago
Role Summary:
This position entails the compilation, review, and submission of pre-meeting packages for authority meetings. The role also involves participating in relevant meetings and handling change requests, non-conformities, and CAPA cases.
Key Responsibilities:- Pre-Meeting Packages: Compile, review, and submit pre-meeting packages to ensure accuracy and compliance with regulatory requirements.
- Meeting Participation: Participate in authority meetings as necessary, contributing to discussions and decision-making processes.
- Change Requests: Handle change requests, non-conformities, and CAPA cases within the assigned area of responsibility, ensuring timely resolution and documentation.
- Document Review: Review device documentation, protocols, and reports to assess their appropriateness for specific regulatory purposes.
- Regulatory Knowledge: Possess a strong understanding of regulatory requirements and guidelines.
- Communication Skills: Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Analytical Skills: Strong analytical skills, with the ability to interpret complex data and regulations.
- Competitive Salary: Receive a competitive salary package.
- Opportunities for Growth: Opportunities for career growth and professional development.
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