Sr. Specialist Regulatory Affairs

Sr. Specialist Regulatory Affairs

Baxter International

San Ġwann, Malta

Essential Duties and Responsibilities

  • Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals;
  • Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals;
  • Track status and progress of regulatory documentation that will be used for renewals;
  • Coordinate and compile responses to regulatory authority renewal questions (under supervision);
  • Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities;
  • Answer internal queries for assigned products;
  • Maintain Database of Regulatory Requirements for renewals.


  • Knowledge of regulations. Medical Device registration/renewal experience preferred;
  • Scientific knowledge;
  • Administrative and project management skills;
  • Ability to contribute to multiple projects from a regulatory affairs perspective;
  • Ability to multitask and prioritize;
  • Interpersonal and communication skills;
  • Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research);
  • Proofreading and editing skills;
  • Ability to independently identify compliance risks and resolve or escalate as necessary.

Education and/or Experience

  • Regulatory experience within a healthcare environment;
  • Bachelor’s degree or country equivalent in a relevant scientific discipline;
  • Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.

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