Ra/Qa - Medical Devices

2 weeks ago

Sydney, New South Wales, Australia Engage Talent Pty Ltd Full time

**The Company**
My client has been a global leader in the Medical Devices industry for over 50 years, providing niche world class products & service to their extensive client base all over the world. The Australian business has experienced a strong growth period in the last 5 years, supported by a dynamic sales, marketing, and customer service function. Due to a number of recent acquisitions, they are looking for a RA/QA Specialist to join the team. With job flexibility & progression, we are looking for a motivated professional to join this modern & progressive company.

**The Role**
- Supporting the development of realisation regulatory strategies
- Ensuring that the company's products are compliant to regulatory requirements; at a minimum for key markets including Australia, Europe and US
- Ensuring that product realisation activities conform with the company's QMS
- Coordinating regulatory strategies and product realisation activities with project teams using the company's project management frameworks
- Analyse local regulatory trends and market intelligent information to make informed decisions, stay abreast of competitor movement and changes
- Assist the Quality Assurance and IP Manager to implement and maintain Quality Systems, Quality Manual, Policies, Procedures and specifications
- Contribute to continuous improvement
- Maintaining device and facility registrations e.g., FDA, AR, TGA

**Preferred Experience**
- Experience in Medical Devices/Healthcare/Pharma
- Qualification in Engineering (preferably biomedical) or similar
- 2 - 3 years of professional experience in regulatory affairs or in quality management systems relating to medical devices
- Experience working in an ISO 13485 regulated environment
- Experience in reading, understanding and implementation of standards for a variety of standards organisations e.g., ISO, IEC, ASTMC
- Excellent communication and interpersonal skills.

You take great pride in contributing to our ability to meet our customer commitments delivering high quality support. To be successful you will need to be flexible and have the ability to develop solid relationships.

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