Regulatory Affairs Specialist - Science & Research jobs in Malta - April 2024
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Regulatory Affairs Specialist

Konnekt

Published on 08 Mar 2024

Expires in 15 days (01 May 2024)


Our client, a global healthcare organization is recruiting for Regulatory Affairs Specialists to join their team. Reporting to the Regulatory Affairs Manager, your duties would include;

  • Creating and reviewing regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals.
  • Interacting with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals.
  • Tracking status and progress of regulatory documentation that will be used for renewals.
  • Coordinating and compiling responses to regulatory authority renewal questions (under supervision)
  • Using an electronic document management system to compile documents to support product renewals for submission to Health Authorities
  • Answering internal queries for assigned products.
  • Maintaining Database of Regulatory Requirements for renewals
Skill-sets and Requirements
  • Regulatory experience within a healthcare environment, specifically Medical Devices
  • Administrative and project management skills
  • Ability to contribute to multiple projects from a regulatory affair perspective
  • Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research)
  • Ability to independently identify compliance risks and resolve or escalate as necessary
  • Ability to multitask and prioritize
  • Based Locally
Education & Experience
  • Bachelor’s degree or country equivalent in a relevant scientific discipline

salary
€28,000 to €35,000 / year
Salary
time
Full Time
Job Type
experience
Experienced (3 years +)
Experience Level
category
Science & Research
Category
industry
Healthcare
Industry


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