Senior Regulatory Associate

About us:
LifeHealthcare, a company of EBOS Med Tech, believe Australian and New Zealand healthcare professionals and patients should have access to world-leading medical devices, whilst ensuring long-term economic sustainability within the healthcare system. As a leading independent distributor of medical technology, we bring innovative medical solutions to healthcare professionals by partnering with world leading companies who share our vision for innovation and making a real difference to people’s lives.
  
At LifeHealthcare, our passion is health, and our purpose is helping to make life better for others. As an organisation, we are guided by a set of values - Accountable, Agile, Authentic and Customer Centric that define our character and culture. We encourage and support employees to live our values every day, whilst offering a range of benefits including health insurance discounts, career opportunities across EBOS Med Tech, generous parental leave, employee referral programs, opportunity to purchase leave, volunteer leave, recharge days and financial rewards for individual and company performance.

The Opportunity:
In this role you will prepare and submit new product registration with the TGA & Medsafe, ensuring regulatory requirements of a diverse portfolio are met. Working within a small and supportive & collegiate team and part of the broader Marketing group, you will be reporting to the Market Access Manager and offering support to others. If 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!
  
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:

• Prepare and submit for TGA Registration Regulatory requirements to comply with Australian TGA and New Zealand Medsafe guidelines and other relevant legislative requirements.
• Liaise with Suppliers (and/or subcontractors) to gain all product information required to register and list products.
• 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.
• Provide guidance and advice on technical issues to less senior team members.
• Provide subject matter expertise to internal business partners, including executive level input on new business opportunities.

And to be successful we think you’ll need:

• At least 5 years’ experience preferably in regulatory affairs in medical device industry, and
• A degree in a related scientific or engineering field will be highly regarded.

LifeHealthcare is a company of EBOS Med Tech, which also includes an allograft manufacturing (Australian Biotechnologies), an Aesthetics business (Cryomed) and a South-East Asian distribution business (Transmedic). The mission of EBOS Medical Technology is to provide life-changing medical solutions to patients across Asia-Pacific. We have over 1,000 employees in the division, with exposure across 9 different countries. This gives us the opportunity to impact a greater number of patients and provide employees with a richer career experience through exposure to various market and therapeutic areas of medical technology.

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*