Regulatory Affairs Specialist

Descripción del Empleo:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
Position Responsibilities :
• Coordinates and prepares document packages for regulatory submissions from all areas of company.
• Compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufa
Requisitos:
Experience in medical device, pharmaceutical, or electronic industry
• Experience in Qualification / Validation activities.
• Experience and Certification in Auditing