Responsibilities may include the following and other duties may be assigned.
*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.
Requirements:
*Bachelors degree required
*Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
*Experience in Medical device or Pharma is essential
*Experience or working with regulatory files for USA / EU
*Lead projects/programs on own initiative and filed them
*Experience working directly with FDA, and notified bodies in the Europe
*Experience working with Class III medical devices or DMS Drug master file
*Experience filing using the ECTS system
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
