Regulatory Affairs Manager

Overview of Role

• Oversee the regulatory activities for an entire product portfolio
• Work directly for a sponsor
• Attractive salary package

Benefits

• 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.

Duties

• 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

Culture

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.