Regulatory Affairs Associate
vor 2 Wochen
Pharmaceuticals & Medical Devices (Healthcare & Medical)Full timeFor more than 35 years, Multigate Medical Products has mastered the growing complexity of Australian Healthcare. By combining the professional competence of a Multi-National company with our family-owned company's virtues and values, we have successfully asserted ourselves within the Australian and International healthcare Industries.Based at our Head Office in Villawood and reporting to our Head of Quality, we are currently seeking a Regulatory Affairs Associate to join our team.Tasks & ResponsibilitiesInitiate, track and facilitate new registrations of medical devices into a relevant registration authority with a focus on the Australian Register of Therapeutic Goods.Manage change to the existing products to ensure registrations remain valid and accurate.Manage accurate technical files for all listed/included products by creating and maintaining the files manufactured by Multigate and ensuring up-to-date documentation is on site or available from suppliers when requested by relevant registration authorities (e.g., TGA).Maintain the ERP database to cross-reference item numbers with the listing/inclusion number.Develop and maintain an effective working relationship with relevant bodies (e.g., TGA).Provide regulatory information and advice to customers, operational staff, and senior management.Conduct internal audits on processes under the quality system.About YouDemonstrable experience within the medical devices or pharmaceutical industry in an Australian or European health-related regulatory position.Qualification in a scientific or health-related discipline.Demonstrated ability in business to manage direct government liaison.Ability to analyse and interpret complex documents.Diversified work culture.Supportive and collaborative environment.Free onsite gym membership and personal trainer.Onsite parking.Close to public transport including Villawood.How do your skills match this job?Sign in and update your profile to get insights.Your application will include the following questions:Which of the following statements best describes your right to work in Australia?What's your expected annual base salary?How much notice are you required to give your current employer?We live in a changing world, and we need to keep changing with it. Our new look Multigate reflects our improving ability to innovate and better serve you, your patients, and our partners.Since our humble beginnings, Multigate has become known as one of the most respected designers, manufacturers, and suppliers of surgical products in Australia.Today, many of our 2000 plus products are in constant use by surgeons and hospital staff working in the emergency ward, operating theatre, and post-op. Our clients choose to use Multigate because we never let them down. They know that our products are manufactured to a level of quality that they can trust, yet are always reasonably priced. More importantly, they know that they can always depend on Multigate to deliver on time.We are the largest designer, manufacturer, and supplier of procedure packs in Australia, with a growing team of passionate professionals. However, in a way, Multigate hasn't changed at all. We are still a company that believes in focusing on our clients' needs and exceeding their expectations.
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