Regulatory Affairs Specialist

  Central Malta  |  €28,000 - €35,000 Annually 

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

Job Reference: WG630

  • Category
    Science & Research
  • Job type
    Full Time
  • Employment level
    Experienced (3 years +)
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Science & Research Jobs in Malta are require the collection, interpretation and analysis of data. Jobs in science and research roles include academic, business analysis, business intelligence, lab, market research, medical, pharma, R&D and statistics roles.

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