Regulatory Affairs Specialist

Requisition ID
2017-3341
# of Openings
1
Job Location(s)
Eight Mile Plains QL Australia
Travel
None
Position Type
Full Time
Expiry Date
15-12-2017
Category
Regulatory Affairs

Overview

 

CookMedicalLogo

 


 World Leading Multinational Organisation
• Working within a highly experienced Regulatory Affairs Team
• Benefits include company monthly bonus and Private Health Cover

 

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.
We have a long tradition of innovation, integrity, loyalty and dedication to customer service at the highest level. Cook companies around the world have always set the highest standards in the medical device industry.


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. Reporting to the Regulatory Affairs Manager, this role is responsible for preparation and submission of relevant information, including pre and post-market clinical evaluation, to regulatory agencies to obtain approvals for Cook products.

 

Cook Can Offer:


• An opportunity for you to join a company that is committed to improving medical care
• A culture that supports personal growth and continuous learning
• Excellent working conditions including subsidised cafeteria and access to onsite gym


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 unites and produces over 7,000 different products for the global market.

 

 

The future of medical care has never been more exciting.

Responsibilities

Key Responsibilities:


• Preparing device submissions, including pre and post-market clinical evaluations, for global markets for all classes of medical devices
• Identifying, reviewing and implementing new or updated regulatory requirements
• Communicating with regulatory bodies including TGA, FDA, and European Notified Bodies
• Provide input and regulatory advise on development and improvement projects, ensuring deliverables comply with relevant regulatory and quality system requirements
• Liaise with all departments within Cook Australia and Cook Companies worldwide to ensure information flow and understanding of current process and regulatory requirements
• Actively contribute to regulatory and quality system compliance improvement initiatives

Qualifications

Key Requirements:


• Tertiary qualifications in either Science, Engineering, Pharmacy or Microbiology desirable
• Experience in Medical Writing and Information Management desirable (e.g. through post-graduate experience in relevant science, or training and experience in systematic review and appraisal of literature and clinical data)
• Experience in Regulatory Affairs within medical device or pharmaceutical industry 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

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