Opportunity to join a fast-growing medical device organization.Competitive salary package.About Our Client This organization is a global leader in medical technology, dedicated to improving patient care through innovative and high-quality solutions.
With a strong presence in Australia, they are renowned for their advanced surgical devices and systems, which are trusted by healthcare professionals worldwide.
Job Description Assess and manage regulatory submission applications ensuring timely approvals and market releases for new products or changes.Review and update product changes, labels, and promotional materials to comply with regulatory requirements.Support with internal training.Regular review of local and global regulatory changes.Collaborate with local and global regulatory teams executing quality and regulatory strategies.Conduct internal and external audits.Review and approve technical documentation for product releases.Monitor, evaluate, and improve quality systems.Provide regulatory guidance to cross-functional teams.The Successful Applicant Skills and Experience:
A tertiary degree in Life Sciences or a related field.Minimum 3 years of local medical devices regulatory affairs and quality assurance experience.Great organizational and project management skills.Comprehensive knowledge of regulatory guidelines and approval pathways in Australia.Exceptional communication skills to effectively liaise with internal and external stakeholders.What's on Offer Hybrid working arrangements.Onsite parking is available.A performance-based bonus.Work with a team that values collaboration, excellence, and continuous improvement.Career progression opportunities.Generous holiday leave allowances.
This is a great opportunity for an RA/QA Officer to advance their career.
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