Regulatory Affairs Specialist

COOK Medical, a global leader in interventional medicine, has sales, marketing and manufacturing offices worldwide. COOK is at the forefront of medical research and product development in minimally invasive health care devices. In an effort to support our continuing growth, we seek the services of a Regulatory Affairs Specialist to join our Australian Head Office at Eight Mile Plains, Brisbane on a 6 month, fixed term contract.

• Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
• Prepare submissions and maintain licenses globally for products manufactured by Cook Australia
• Maintain Medial Device Files and other regulatory documentation
• Maintain regulatory license databases and systems which contain regulatory approval or restriction information
• Communicate with regulatory agencies and conformity assessment bodies as necessary
• Provide regulatory support to engineering projects as necessary
• Review global marketing materials for compliance to relevant advertising guidelines
• Provide regulatory compliance input to development and improvement projects, ensuring deliverables comply with relevant regulatory and quality system requirements
• Conduct Gap analysis and prepare regulatory strategy/plans for new or changed regulatory requirements

• Tertiary qualification in either science, engineering, pharmacy or microbiology highly desirable
• Experience in either quality assurance or regulatory affairs within a highly regulated industry highly desirable
• Experience preparing regulatory submissions desirable
• Experience with clinical writing and data analysis desirable
• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
• Analytical approach to problem solving with innovative thinking
• Highly organised with a focus on attention to detail
• Approach daily tasks with flexibility, initiative and enthusiasm
• Effective interpersonal skills including listening, verbal and written communication skills
• Ability to work effectively in a team environment

 Cook Can Offer:

• Friendly, supportive and collaborative team environment
• An opportunity for you to join a company that is committed to improving medical care
• A culture that supports personal growth and continuous learning

Cook as an Employer:

Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a private corporation. The Australian Head Quarters is located in the Brisbane Technology Park, Eight Mile Plains, Queensland. Our manufacturing operation is steadily growing and manufacturing more complex devices for our global markets.

Cook Medical has over 10,000 employees worldwide, operates directly in 39 countries and delivers products to 135 countries around the world. Cook Medical consists of nine business units and produces over 7,000 different products for the global market. The future of medical care has never been more exciting.

For more information about Cook Medical, visit http://www.cookmedical.com.au