Senior Regulatory Associate

at  LifeHealthcare

• Opportunity to grow your career and make a difference in the lives of others
• People First Culture where talent is rewarded
• Role can be based in Sydney, Brisbane or Melbourne - we are flexible

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!

• 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.