Regulatory Affairs Manager

Requisition ID
2021-9422
# of Openings
1
Job Location(s)
Eight Mile Plains QL Australia
Position Type
Full Time
Expiry Date
1-10-2021
Category
Regulatory Affairs

Overview

Life at Cook Medical:

Our culture and values are something we are proud of. With Cook Medical, you will be joining an inclusive culture that truly values its people. We are passionate about the work that we do in making a difference to patient lives around the globe. We treat everyone with respect and encourage our employees to be transparent, through open and honest communication and being appreciative of individual contribution.

 

Company History:

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. Headquartered in the United States, we also have manufacturing locations in Denmark, Ireland and Australia. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. As a global, modern company we ensure that our company values reflect our everyday business practices, staying true to what Bill and Gayle Cook started in 1963. 


The Role:

We are looking for an enthusiastic individual with a strong work ethic to join our friendly, well respected and long-established company. You will be joining a dynamic team where you can establish long-lasting working relationships with your immediate peers and the wider company.

Responsibilities

  • Ensure personal and team compliance with company values, quality system procedures, policies and relevant medical device standards and regulations
  • Provide guidance and supervision to team members regarding preparation of Regulatory Submissions for Cook products
  • Provide regular updates to all Sales Divisions regarding regulatory strategy, status of regulatory submissions and maintenance of priority lists for upcoming product applications
  • Negotiate with the TGA on behalf of overseas Cook companies as agreed and required
  • Coordinate with regulatory staff and relevant Cook manufacturers to propose and execute effective strategy and tactics to obtain marketing approval for Cook products
  • Liaise with all relevant distributors and Cook companies worldwide to ensure information flow and understanding of current processes
  • Disseminate Regulatory trends and information to key Cook staff to ensure the organization is up to date with current Regulatory practice in Australia as well as major markets for Cook products
  • Ensure that the post-market surveillance obligations are complied with

Qualifications

  • Tertiary qualifications in law, science, medicine, engineering, pharmacy, microbiology or another relevant scientific discipline and professional experience in regulatory affairs or in quality management systems relating to medical devices
  • Extensive knowledge and understanding of regulatory requirements of key jurisdictions is essential (though some may be acquired after being appointed to this role), such as for Australia, USA, EU, Japan, Brazil, Canada and China
  • Experience in managing people and or projects across different countries and cultures
  • Highly developed communication and interpersonal skills

 

What’s in it for you?

  • Stability of a long-established company
  • Values recognition and service awards
  • Performance based quarterly bonus
  • Top Hospital Private Health Cover for immediate family
  • Flexible start/finish times
  • Ongoing training and development
  • Access to educational assistance

 

Candidates applying to this role must be a permanent resident or citizen of Australia. 

 

This role is to commence as soon as possible and shortlisting will commence immediately. 

 

At Cook Medical, we embrace diversity and inclusion. We understand that everyone can offer a unique perspective and can contribute their own ideas to improve how we work. We strive to create an environment where our employees can feel empowered to make decisions and can bring their full, authentic selves to the workplace.

 

We are seeking conscientious employees who align with our values, and we encourage people of all genders, races, ages and abilities to apply for roles within our organisation.

 

For more information please visit www.cookmedical.com.au/careers

 

The future of medical care has never been more exciting.

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