RA/QA Officer
Michael Page Sydney
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.
- 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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