Regulatory Affairs Specialist

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 have an excellent opportunity for a regulatory professional to join our Regulatory Affairs team on a 12-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**:
**Key Responsibilities include but are not limited to**:

- Prepare Medical Device Files for submission to regulatory authorities, with a focus on European Notified Bodies
- Maintain Medial Device Files and other regulatory documentation
- Maintain regulatory license databases and systems which contain regulatory approval or restriction information
- Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
- Communicate with regulatory agencies and conformity assessment bodies
- Provide regulatory support to engineering projects, as necessary
- Review global marketing materials for compliance to relevant advertising guidelines
- Perform administrative tasks, including document formatting, and preparing documentation for the internal change control process.

Qualifications:
**Do you have what it takes?**

To be successful in this role, you will have the following:

- Experience creating regulatory documentation for submission to regulatory authorities is essential
- 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
- 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
- Proficient in Microsoft Word and Adobe Acrobat

**What’s in it for you?**
- Stability of a long-established, global company
- Flexible start/finish times
- Flexible work location

**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.

**The future of medical care has never been more exciting.