North Ryde, NSW, AU, 2113
Regulatory Affairs Specialist
At LifeHealthcare, we’re on a mission to deliver life-changing medical solutions to patients across Australia and New Zealand. Our passion is health, and our purpose is making life better for patients, our partners, and our people.
We are part of EBOS MedTech, which operates in 9 countries through its portfolio of companies: LifeHealthcare (ANZ distribution), Australian Biotechnologies (allograft manufacturing), Cryomed (aesthetics), and Transmedic (SE Asia + Hong Kong distribution).
Across all these businesses, we are guided by a shared value: Connect. This reflects our commitment to building meaningful partnerships, sharing knowledge, and working together to create greater impact for the people and communities we serve.
In this role you will be responsible for the execution of pre market regulatory submissions and Lifecycle management activities in accordance with Australian and New Zealand Sponsor obligations. As part of a small and collaborative team you will support timely product registration and lifecycle compliance whilst maintaining clear separation from post market vigilance activities. This role can be based in NSW, Queensland or Victoria.
Responsibilities:
- Prepare and submit ARTG and WAND inclusion applications across all relevant medical device classifications.
- Support determination of device classification and regulatory pathways under supervision of the Regulatory Affairs Manager.
- Review manufacturer technical documentation e.g. DoCs, certificates to support Sponsor conformity evidence requirements.
- Execute Tier 1 lifecycle variations and renewals e.g. administrative changes, non safety impacting updates.
- Maintain regulatory records, databases, and submission tracking tools.
- Support regulatory change impact assessments and implementation activities.
- Partner with Commercial, Marketing, and Operations teams to support pipeline prioritisation and launch readiness.
Skills and Experience:
- 3+ years Regulatory Affairs experience within medical devices (ANZ preferred)
- Demonstrated experience preparing ARTG / WAND submissions
- Experience in Class III Medical Devices, preferably in Spine or Orthopaedics
- Strong knowledge of TGA and Medsafe regulatory frameworks
- High attention to detail and audit‑defensible documentation practices
- Ability to interpret regulatory requirements and apply them to submissions
LifeHealthcare is guided by a set of values; Accountable, Agile, Authentic, and Customer Centric that define who we are and how we work. We encourage and support our employees to live these values every day, and we offer a range of benefits to help you thrive, including:
- Health insurance discounts
- Career opportunities across the EBOS MedTech portfolio of companies
- Generous parental leave
- Employee referral programs
- Option to purchase additional leave
- Volunteer leave
- Flexible work arrangements
- Performance-based financial rewards for both individual and company success
If this sounds like something you want to be part of, apply now and be part of EBOS MedTech and it’s portfolio of companies that are changing lives together, starting with you.
