Regulatory Affairs Associate

1 week ago


Bowen Hills, Australia LifeHealthcare Full time

Flexible working arrangements
- Flexible, supportive & friendly environment
- Excellent rewards for high performing employees

LifeHealthcare is a leading independent distributor of high-end medical devices in Australia and New Zealand. We bring innovative medical devices to healthcare professionals by partnering with world class companies who share our vision for innovation and making a real difference to people’s lives.

While the products we bring to the market are a cornerstone of our achievements to date, our real success has been delivered through the quality of our people and partners.

LifeHealthcare is the Medical Technology Division of the EBOS Group. With almost 5,000 employees in 109 locations in Australia and New Zealand, and Southeast Asia, EBOS is the largest and most diversified Australasian marketer, wholesaler and distributer of healthcare, medical and pharmaceutical products. It is also a leading marketer and distributor of recognised animal care brands. EBOS is a publicly listed on the New Zealand and Australian stock exchanges.

If coordinating new product registration with the TGA & Medsafe, whilst meeting regulatory requirements of a diverse portfolio and playing a key role in giving patients access to innovative technologies drives you to succeed, then our Regulatory Affairs Associate role may be just what you’re looking for Working within a small and supportive team and part of the broader Marketing group, you will be reporting to the Senior Regulatory Associate. This role is an appealing opportunity for someone interested in building a strong career in Medical Device Regulatory Affairs.

**You’ll stand out from the crowd if you**:

- Understand legislation governing regulation of medical devices in Australia & New Zealand
- Have knowledge of requirements for ongoing registration of products and experience managing recall processes
- Have an excellent ability to grasp new concepts quickly and to assimilate data from a range of scientific areas.
- Possess excellent communication skills, both written and verbal
- Demonstrate a can-do attitude and hands on work style.

**You’ll be responsible for**:

- Coordination & maintenance of LifeHealthcare’s pre and post market Regulatory requirements to comply with Australian TGA and New Zealand Medsafe guidelines and other relevant legislative requirements
- Providing regulatory bodies with required reports/reviews (for example, annual reporting, post market reviews & general enquiries)
- Informing and prepare the business for upcoming legislative changes which may have a commercial impact

**And to be successful we think you’ll need**:

- At least 1 to 3 years’ experience preferably in regulatory affairs in medical device industry, and
- A degree in a related scientific or engineering field will be highly regarded

**Culture and Benefits**:
At LifeHealthcare, our passion is health, and our purpose is helping to make life better for others. As an organisation, everything we do is guided by a set of values that define our character and culture - Accountable, Agile, Authentic and Customer Centric - and we are driven to succeed in delivering the best outcomes for our patients. This is a real opportunity for you to make a difference in the lives of others and to influence change in our fast
- growing organisation.

People are at the centre of everything we do, and we value and encourage you to be your authentic self, and to this end, we offer well-being benefits, health insurance discounts, career growth, generous parental leave, employee referral program, purchase leave, volunteer leave, flexible work arrangements and financial rewards to promote excellence in our employees. Our offices are easily accessible by public transport and we offer free onsite parking.

If this all sounds like something you want to be a part of, APPLY now and watch your career grow as you select the footprint to influence access to the best medical technology for our patients.
- *No agencies please, we have this one covered*_


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