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Regulatory Affairs Associate

1 month ago

Sydney, Australia Healthcare Professionals Group Full time

**Benefits**
- Great role to join a collaborative Medical Device organisation.
- Exposure to diverse medical device portfolio
- Hybrid working environment

**About the Company**
Our client is a leading Medical Device organisation with a strong presence in Australia, New Zealand, and Asia - they have a focus on quality and dedicated support, the company has built a strong reputation in the healthcare industry.

**About the Opportunity**
As a Regulatory Affairs Associate, you will be responsible for managing a specific portfolio of medical device TGA and Medsafe registrations. You will work closely with internal stakeholders and external manufacturing partners to optimise submission strategies and ensure compliance with regulatory frameworks. Your role will contribute directly to the success of our client in delivering high-quality, innovative products to Australian and New Zealand patients.

This role is a hybrid position and there is flexibility to work from home.

**Duties**
- Manage TGA and Medsafe registrations for medical devices across all classes
- Maintain records and registrations in online platforms
- Investigate and resolve labelling problems in quarantined products
- Collaborate with internal teams and external partners to meet business launch deadlines
- Ensure compliance with regulatory frameworks applicable to the company's products

**Skills and Experience**:

- Experience working in the Medical Device industry in a regulatory affairs role.
- Knowledge of Australian and New Zealand medicine and medical device regulatory requirements and processes.
- Good understanding of the advertising code of practices and some experiences in reviewing promotional materials
- Effective written and verbal communications.
- Self-motivated & results orientated
- SAP experience

**Culture**
At our client, we foster a culture of innovation, collaboration, and ownership. We value fresh ideas, support each other's goals, and encourage accountability. Our success is built on continuous improvement and creating an environment where all voices are heard.

**How to Apply**
Click "Apply" or contact Gemma Staddon, Specialist Manager, on 02 8877 8776 for a confidential discussion.

**Job details**:

- Location
- Sydney
- Salary
- Competitive
- Job Type
- Full Time
- Ref
- BH-40237
- Contact
- Gemma Staddon
- Contact phone
- +612 8877 8776
- Posted
- 29 minutes ago