Sr. Specialist Regulatory Affairs

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Baxter International

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.

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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