Regulatory Affairs Associate

3 months ago

North Ryde, Australia 3M Full time

**Job Description**:
**Responsibilities**:
1.) Ensure regulatory compliance of the Health Care Business products for ANZ. Develops and maintains documentation relevant to assessment of risk to human health and the environment. Performs post market activities and reviews Advertisisng collateral for compliance. Prepares and files regulatory document to Australia and New Zealand Healthcare Authorities for registration.

2.) Perform and guide activities resulting from approved self-initiated or assigned programs leading to the regulatory compliance, assessment of safety to human health and liability avoidance, and product responsibility issues concerning existing or new therapeutic products.

3.) Communicate with legislators on:

- Adverse incidents including non conforming products
- Product registration
- Post market product activity compliance

4.) Business support including:

- Review promotional activities
- Review Artwork/ Packaging materials supporting compliance and registration of product

5.) Pursue continuing education efforts to develop advanced knowledge of regulatory requirements, in consumer healthcare regulations, product responsibility skills and knowledge, and business, including an understanding of technologies applicable to the job requirements.

LI-Remote

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