- Global, leading manufacturer of medical devices.
- Their products are sold in over 100 countries, and they pride themselves on being different.
- It's this spirit that helps them provide advantages to both patients and clinicians and they are an entrepreneurial force that drives innovation.
- This organisation has a great culture, and the work environment is collaborative and friendly, it’s a great place to work!
- Their Employee Value Proposition is outstanding, and they are constantly making sure their culture is people focused!
- This role will see your career soar to new heights! Scope to grow and develop!
- This Head of RA/QA position is responsible for leading all the Regulatory Affairs, Medical Device Compliance and Quality Management Systems implementation. This individual will be the leader of the RA/QA function and a proactive business partner as part of the ANZ senior leadership team.
- This role will follow regulatory strategy for assigned corporate projects and obtain approvals for ANZ regulatory submissions and will ensure the Quality System is implemented to align with local regulatory requirements for ANZ operations.
- The focus of the role will be to translate regulatory and quality requirements into practical, innovative, workable, solutions-oriented plans via interacting directly with local authorities, global RA/QA.
- The position will ensure product launches and distribution compliance with applicable local regulatory and quality requirements and collaborate with global QA on local complaint investigations, adverse event reporting, product recall, field safety notices and corrective actions.
- You will lead the ISO13485 certification of local entity and maintain quality system documents and act as a resource to the local site on quality issues and propose changes to minimise risks and enhance product quality, reliability and safety.
- You will collaborate with global RA on the review and approval of product labelling to ensure compliance with applicable local regulations and collaborate with local marketing on the review and approval of promotional materials to ensure compliance with company policies and external standards.
- Strong knowledge of ANZ and international business medical device regulatory environments/regulations, ISO13485, and legal product registration processes.
- Strong computer, problem solving, analytical skills, and excellent English communication, with full Australian working rights.
- Minimum 8 years of in-depth and hands-on experience in the medical device industry dealing with international country registrations including Class II and Class III devices.
- 3 years in an RA/QA leadership role working in ANZ.
- Key deliverables in the first 12 months will be leading the business through an external audit to have the ANZ QA system certified. So, the successful person will have experience getting certification to ISO13485 in a previous business. If you also have an internal audit certification that will be a big advantage.
- Bachelor’s Degree in a technical and scientific discipline.