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.
|Requisitos - Requirements
Background: Educational: BS. Science, Engineering, or related field
0-3 Years with Dilpoma Degree
Exposure to compliance, configuration, documentation, quality systems, validation requirements, quality engineering, auditing, laboratory or regulatory manufacturing environment
Technical Writing Skills
Quality and Results Oriented
Fluency speaking and writing in English and Spanish
Desired/ Preferred Qualifications
Experience in medical device, pharmaceutical, or electronic industry
Experience in Qualification / Validation activities.
Experience and Certification in Auditing
Root Cause Analysis
Alternate Job Title
Associate Regulatory Af