Business: LifeHealthcare
Location:
North Ryde, NSW, AU, 2113
#job-location.job-location-inline { display: inline; }
Employment Type: Permanent Full Time
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, and be part of EBOS MedTech and it’s portfolio of companies that are changing lives together, starting with you.
