Responsibilities
Direct growth, innovation and post-marketing Lifecycle Management activities, including claims, renewals, labelling and copy clearance
Lead regulatory strategies and submissions to health authorities, ensuring ongoing post-market compliance
Partner with regulators and trade associations to resolve issues and influence policy in line with business strategy
Anticipate emerging risks and drive best-practice regulatory policies, processes and SOPs
Develop the team, influence as a key leadership team member and manage the department budget
About You
Bachelor's degree in a scientific discipline (Master's preferred) with 6–8 years' related experience, ideally in medical devices
Expert knowledge and practical application of regional government regulations
Sound regulatory and business strategy expertise to gain and maintain the legal marketing status of a product portfolio
Excellent organisational, communication and negotiation skills, with the ability to influence senior leaders, affiliates, regulators and industry
Willingness to travel domestically and internationally (approx. 10%)
Why Choose Us
Competitive remuneration package
Continuous training and support
Award-winning leadership development programs
Inclusive, flexible, and accessible working arrangements
Equal opportunity employer supporting diversity and inclusion
Our Benefits
Up to 18 weeks of parental leave to support new parents
4 days of volunteer leave to give back to the community
Option to purchase up to 2 weeks of additional annual leave for extra time off
Enjoy a dedicated Wellbeing Day to prioritise self-care
Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
Access to an Employee Assistance Program for personal and professional support
Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
Life insurance coverage for added peace of mind
And much more...
All applicants must have rights to work in Australia.
Required Skills
Preferred Skills
Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking
