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Regulatory affairs officer

Swansea (NSW)
Paragon Care Group
Posted: 26 May
Offer description

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Senior Talent Acquisition Partner @ ParagonCare Limited | Talent Acquisition & Recruitment Specialist

The Opportunity

Paragon Care is seeking a detail-oriented and proactive Regulatory Affairs Officer to support and action our regulatory and compliance activities across the business - Based in Eastern Creek .

In this vital role, you will help ensure our therapeutic goods meet all applicable regulatory and statutory requirements, fostering seamless collaboration between internal and external stakeholders.

Key Responsibilities | Regulatory & Compliance:

* Support compliance with all relevant healthcare and therapeutic goods regulations in Australia.
* Communicate effectively with regulatory bodies, including the TGA and State Health Departments.
* Assist with relevant licensing and permit activities.
* Maintain regulatory technical files and approval directories.
* Conduct recall actions and assist with reporting requirements.
* Assist in post-marketing surveillance activities including adverse event reporting.
* Identify and implement opportunities for continuous improvement in regulatory processes.

About You:

You’re a highly organised, proactive self-starter with a sharp eye for detail and a strong results-driven mindset. A clear and confident communicator, you thrive in collaborative environments and bring persistence, patience, and creative problem-solving to every challenge.

* Several years’ experience in a healthcare regulatory or compliance role.
* Knowledge of medical device and/or pharmaceutical regulations.
* Strong verbal and written communication skills.

Technical Skills:

* Familiarity with regulatory requirements in the medical device and pharmaceutical sectors.
* Understanding of quality management systems.
* Competent in Microsoft Office Suite (Excel, Word, PowerPoint, database tools).
* Excellent numeracy and data interpretation skills.

About Us:

Paragon Care is an ASX-listed industry leader in the healthcare industry, specialising in supply and service of advanced medical equipment, devices, and consumables.

With an unwavering commitment to innovation and excellence, Paragon Care is at the forefront of transformative healthcare technologies, dedicated to shaping the future of patient treatment and healthcare decision-making.

What’s in it for you:

At Paragon Care, we are committed to providing a supportive and collaborative work environment where your contributions are truly valued. You will have the opportunity to work on cutting-edge technology, engage with a diverse range of stakeholders, and continuously develop your regulatory skills.

If you are passionate about making a difference in the world of healthcare, we want to hear from you! Join our team today and embark on an exciting journey where your expertise will have a lasting impact. Apply now and take the first step toward a fulfilling and rewarding career!

We're not engaging any recruitment agencies for this role, so if you're interested. Please apply directly!

Successful applicants will be required to complete a pre-employment medical that includes an illicit substance test and criminal history check prior to commencement of employment. Only open to Australian or New Zealand Permanent Residents or Citizens. Paragon Care fosters a workplace that actively seeks to include, welcome and value the contributions of all people and encourages people with a disability, Aboriginal and Torres Strait Islander people, and people from culturally diverse backgrounds to apply.


Seniority level

* Seniority level

Mid-Senior level


Employment type

* Employment type

Full-time


Job function

* Job function

Science
* Industries

Hospitals and Health Care

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