Our client is looking for a Senior Regulatory Affairs Specialist - 12 month contract.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 systemIf you would like to hear a little bit more about it, please email me your CV to firstname.lastname@example.org or apply in the link below.