Senior Regulatory Affairs Specialist - 24 month contract

Requisition ID
2021-8691
# of Openings
1
Job Location(s)
Eight Mile Plains QL Australia
Position Type
Temporary
Expiry Date
2-5-2021
Category
Regulatory Affairs

Overview

  • Friendly, supportive and collaborative team environment
  • Contribute to patient outcomes, what a great reason to come to work!
  • Strong inclusive culture that values our people

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 have an excellent opportunity for an experienced regulatory professional to join our Regulatory Affairs team on a 24-month contract.

We are looking for a hard-working, reliable and motivated individual to join a dynamic team where you can establish positive working relationships with your immediate peers and the wider company.

Responsibilities

  • Develop and execute regulatory strategy for submission of medicinal component of medical device in the EU market.
  • Prepare submissions for medicinal components of medical device to European regulatory authorities.
  • Adapt Medical Device Files to be compliant with EU MDR requirements for a medical device family that contains ancillary medicinal components.
  • Assess the acceptability of quality, preclinical and clinical documentation to comply with applicable regulations.
  • Review and update regulatory department processes and procedures as required

Qualifications

  •  Extensive regulatory experience in a design, manufacturing, or consulting environment
  • Experience preparing submissions for medical devices containing ancillary medicinal substances in the EU is highly desirable
  • Experience creating, compiling, and maintaining regulatory documentation is essential
  • Tertiary qualification in either science, engineering, pharmacy, or microbiology
  • Understanding of medical device regulations in the European Union and Australia
  • Experience in either quality assurance or regulatory affairs within a highly regulated industry
  • Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
  • Analytical approach to problem solving with innovative thinking
  • Highly organized 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

What’s in it for you?

  • Stability of a long-established company
  • Flexible start/finish times
  • Option to work remote
  • Ongoing training and development

 

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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