Senior / Regulatory Affairs Associate, Devices – Medical Developments International Ltd – Melbourne

Medical Developments International (MDI) is a leading manufacturer and distributor of medical products used for Healthcare solutions for more than 30 years. MDI has a portfolio of world class products and a strong existing business. We are leaders in two of the markets we operate in and our portfolio of business opportunities is substantial and deliverable in the near term.

We are seeking a Regulatory Affairs Associate to join our growing team with experience in pharmaceutical , medical devices and/or other regulated environments. The successful candidate will ensure quality standards are met across multiple projects.

Specifically this role will require:

Working on regulatory submissions for various projects to ensure cost effective, compliant products are registered;
Experience in pharmaceutical manufacturing, and providing regulatory leadership and strategy required to achieve regulatory approvals;
Experience in the preparation, compilation and submission of high quality applications including marketing authorisation applications, variations, renewals and responses to regulator questions;
Experience in writing applications for registration including solid understanding and experience in preparation and compilation of CMC documentations to ensure compliance for regulatory approval;
Working and communicating effectively across many countries and cultures;
Supporting the Regulatory Affairs team in the regulatory assessment and due diligence of product development opportunities;
Developing and maintaining internal systems to meet and exceed quality and regulatory standards;
Exposure to managing clinical trials, eg managing essential documents including protocols, patient consent forms; managing CROs, contract laboratories, etc. to meet deadlines;
Exposure to promotional materials from compliance with code of conduct and in reviewing labelling and packaging artwork.

The following experience will be required for this role:

Science degree (chemistry/biology or pharmacy preferred)
3 + years’ experience in the pharmaceutical industry
Excellent communication skills
Technical writing skills
Ability to work independently
Intermediate MS Office
Attention to detail

Please forward your CV to Mary at or apply here.