Regulatory Affairs Associate

6 days ago

Sydney, Australia Bausch + Lomb Full time

REGULATORY AFFAIRS ASSOCIATE - Fixed Term Control

Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world - from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.

We have an 6 month opportunity for a full-time Regulatory Affairs Associate to join our regulatory team.

**In this role your key responsibilities will be to**:
Assist with the registration of new products and the maintenance of approved products in order to ensure compliance of registered products in the marketplace.

Compile quality registration dossiers, ensuring their timely submission, and responding effectively and efficiently to Health Authorities requests to achieve a favorable outcome.

Reviewing artwork and labelling for compliance with relevant regulations and guidelines.

Providing accurate and timely regulatory advice to the business teams, including the review of TGA and Medsafe consultation documents and proposed changes in the external regulatory environment.

Review promotional materials in compliance with regulations.

Maintain local regulatory generated registration details, including Product Master Files and Registration Tracking.

**Requirements for the role**:
Minimum of 2 years experience working in medical device regulatory affairs

You must have knowledge of Australian and New Zealand medical device requirements and processes.

An understanding of the product commercialisation process will be advantageous.

Tertiary qualifications in a pharmacy or life science discipline is essential.

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