Job Description

2 days ago Be among the first 25 applicants

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Direct message the job poster from Healthcare Professionals Group

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Divisional Manager @HPG - Recruiting, Medical Affairs, Regulatory Affairs, Health Economics & Market Access professionals into the Pharma, Biotech &...

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Benefits
n • Work with a global leader in medical technology
n • Opportunity to contribute to a high-impact product launch
n • Collaborative environment with flexibility and autonomy
n About the Company
n Our client is a global healthcare leader renowned for developing innovative, life-changing technologies in medical devices. With a strong presence in Australia and across international markets, they are committed to improving patient care and advancing the future of healthcare.
n About the Opportunity
n This is an exciting opportunity to step into a Senior Regulatory Affairs Associate role, supporting a high-priority product portfolio during a critical period of growth. With a significant product launch approaching and regulatory demands increasing, this position is instrumental in ensuring efficient, compliant, and timely pre-market submissions. Reporting to a seasoned Regulatory Affairs Manager, you'll play a vital role in regulatory strategy and operations for the ANZ region.
n Duties
n • Manage end-to-end regulatory submissions, including TGA interactions
n • Lead regulatory strategy and compile technical files, primarily adapted from EU documentation
n • Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices
n • Review local documentation and assess non-conformance where required
n • Evaluate the regulatory impact of product and process changes
n • Review promotional and advertising materials for compliance
n • Provide regulatory support to cross-functional teams, including commercial and market access
n Skills and Experience




n • Tertiary qualification in a scientific or healthcare-related discipline
n • Minimum 3 years of Regulatory Affairs experience in medical devices
n • Strong technical writing experience, especially with regulatory files
n • Experience working on TGA submissions and promotional material reviews
n • Intelligent, adaptable, and a strong communicator across functions
n • Self-motivated, proactive, and capable of managing priorities in a quick-paced setting
n Culture
n You'll join a lean but dynamic and growing team that values innovation, autonomy, and open communication. This is a culture where big-picture thinkers who also dive deep into detail will thrive. The leadership style is supportive but hands-off, suited to someone emotionally mature and confident in self-managing their workload.
n How to Apply
n Ready to contribute to a high-impact medical device launch? Click apply or contact Gemma Staddon - gstaddon@hpgconnectfor a confidential discussion.
n About Healthcare Professionals Group
n Healthcare Professionals Group recruits all positions across healthcare – Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care.
n • Medical Affairs & Life Sciences – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific
n • Commercial – Marketing, Sales, Analytics, Government & External Affairs
n • Business Operations & Infrastructure – Administration, Finance, HR, Legal, Supply Chain, IT
n • Clinical Care – Allied Health, Aged Care, General Practice, Nursing, Medical Imaging

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Seniority level

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Seniority level

Not Applicablen

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Employment type

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Employment type

Contractn

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Job function

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Job function

Sciencen

Industries

Medical Equipment Manufacturingn

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📌 Senior Regulatory Affairs Associate (New South Wales)
🏢 Healthcare Professionals Group
📍 New South Wales