Oversee the regulatory activities for an entire product portfolio
Work directly for a sponsor
Attractive salary package
Work for a world leading Medical Technology company
Oversee an exciting product portfolio
Inclusive work culture with opportunity for career growth
Flexible work from home arrangements
About the company
World leading medical technology company that has an outstanding reputation and that has been developing lifesaving medicines for decades.
About the opportunity
Working within the ANZ regulatory team your main responsibility will be to oversee the regulatory activities of a product portfolio. You will work closely with local businesses and functional counterparts to ensure the business success of company.
Manage regulatory submissions to TGA , MedSafe and other relevant regulatory authorities and manage all permits
Manage product registrations and conformity assessments for medical devices
Manage all documentation and ensure company compliance with local regulations
Manage field actions by collaborating closely with regulatory bodies and local businesses
Contribute to training and development of staff and assist in process improvement
Manage promotional content by liaising with external and internal parties and ensure compliance with relevant guidelines
Liaise with global leaders and ensure all work activities are compliant with the companies' internal SOP's
Provide regulatory expertise to internal and external parties over regulatory strategies and industry trends
Skills and Experience
Tertiary qualification in a relevant discipline
Ideally 10 years' experience in regulatory affairs, preferably medical devices
Excellent understanding of TGA and MEDSAFE guidelines
High attention to details and understanding of quality management systems
Full Australian working rights
Global company that has some game changing products but also prides itself on having a collaborative approach to work and encourages networking and a family style management structure.
How to Apply
Click apply or contact Joanna Murphy, Sourcing Consultant on +61 2 8877 8718 for a confidential discussion.
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