Post-Market Quality & Regulatory Manager

About the company

A large and established, Australian, medical supplies organisation with a broad range of well-known brands across the hospital and healthcare sector.

About the opportunity

The Post-Market Manager will lead the RAQA Post-Market team in efficient and timely processing, analysis, evaluation, and implementation of product complaints, adverse events, and recall actions. This is a permanent opportunity reporting to the Head of Quality & Regulatory.

Duties

• Ensure all post-market vigilance and monitoring activities are conducted in accordance with local regulatory and legal requirements for all product ranges.
• Develop and maintain efficient reporting of operational performance indicators for product complaints, adverse events, and market actions
• Collaborate with QARA Management, Business Management, and cross-functional teams to identify and resolve areas of concern relating to post-Market product quality.
• Develop and maintain excellent working relationships with relevant regulatory bodies and government departments
• Ensure delivery of high-level internal and external customer service by the QARA Team
• Identify, lead, and facilitate improvement projects related to the Post-Market QARA Team
• Actively influence and manage overall performance of the team

Skills and Experience

• Minimum of 5 years' experience working in the Australian medical device industry in either Quality or Regulatory role
• Well-developed leadership, interpersonal, communication and organisational skills
• Working knowledge of medical device post-market vigilance and monitoring activities
• Tertiary qualification is Science or Engineering
• Experience managing a team of direct reports
• Excellent software skills - desirable; SAP, SharePoint, PowerPoint, Adobe Professional

Culture

Diverse and inclusive environment with people who are passionate about their roles and motivated by a common goal of empowering the Australian healthcare landscape.

How to Apply

To be considered for this position, please click apply and submit your application in the first instance. If you have questions about the role please contact Joanna Murphy, Specialist Manager; Regulatory & Quality on +61 2 8877 8718 or jmurphy@hpgconnect.com for a confidential discussion.