Senior Regulatory Affairs Associate

Description:

Benefits
• Work with a leading Healthcare company with a global presence
• Collaborative environment with a supportive team in place
• Competitive salary package + bonus
About the Company
Our client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medical Devices.
About the Opportunity
Join as a Senior Regulatory Affairs Associate, where you will play a pivotal role in our client's regulatory processes. Responsible for managing submissions, developing regulatory strategies, and fostering key relationships, you will contribute significantly to the success and competitiveness of our client in the dynamic medical device industry. Reporting to the Regulatory Affairs Manager, this position offers a unique opportunity to impact the business at a strategic level, ensuring compliance and efficiency in a global context.
Duties
• Lead and manage regulatory submissions to ensure timely approvals.
• Develop and implement effective regulatory strategies for streamlined submissions.
• Prepare and compile comprehensive regulatory documentation packages.
• Evaluate the impact of changes on the regulatory status of products.
• Build and maintain positive relationships with regulatory authorities.
• Provide valuable regulatory advice to diverse cross-functional teams.
• Support health economic submissions and contribute to tender processes.
• Actively participate in compliance-related activities, including audits.
• Review and enhance processes related to regulatory activities, ensuring efficiency and adherence to industry standards.
Skills and Experience
• Relevant degree in a science discipline.
• Minimum 3 years Regulatory Affairs experience in Medical Devices.
• In-depth knowledge of global regulatory requirements, ensuring compliance and strategic planning.
• Showcase a track record of independently preparing and submitting complex regulatory documents with precision and efficacy.
• Strong communication skills
• Collaborative approach
Culture
Our client cultivates a dynamic and collaborative company culture, emphasizing innovation, integrity, and a commitment to improving healthcare. Join a team dedicated to making a meaningful impact on patient lives in a supportive and inclusive work environment.
How to Apply
Click 'Apply' or contact Gemma Staddon, Specialist Manager, at 02 8877 8776 for a confidential discussion.