Regulatory Affairs Specialist - 12 Month Fixed Term Contract

Reporting to the Team Lead, Regulatory Affairs, you will join a diverse group of experienced RA professionals to serve as a regulatory professional focusing on regulatory submissions for medical devices. This role offers exposure to EU regulatory pathways as well as submissions across APAC and Latin America, working closely with cross-functional teams to support global regulatory compliance and product lifecycle activitiess.

• 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.

We are seeking people who align with our company values and have a passion for compliance. To be successful in this role, you will be able to demonstrate the following skills and experience:

• Tertiary qualification in a technically related field i.e., Science, Engineering etc. essential.
• Experience working in a highly regulated industry such as medical devices desirable
• Experience preparing regulatory submissions desirable
• An understanding of quality control / assurance in a manufacturing environment essential.
• Critical thinker, encourage innovation and continuous improvement
• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
• Highly organised with a focus on attention to detail
• Personal accountability with a process efficiency focus
• Effective problem-solving skills.

Employee Benefits:

• Work from home 1-3 days per week
• Base salary plus performance-based quarterly bonus and annual leave loading
• Prioritise your physical and mental wellbeing with access to onsite gym and our employee assistance program
• Subsidised cafeteria, wellness room and prayer room

About us:

Since 1963, Cook Medical have been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities.

At Cook Medical, we use our high ethical standards and core values to guide our decisions and actions. We approach innovation by first listening to understand and then creating a solution. 

Supporting a Diverse Workforce:

We are proud of our diverse workforce and value individual contribution. We appreciate that every employee can add value to our organisation in their own unique way and want to ensure that our company culture stays balanced and strong. 

We encourage applications from Indigenous Australians, people with disability, those from diverse cultural backgrounds, people from the LGBTQI+ community, and anyone else who wants to be a part of our Cook Australia family.

Community Commitment:

Our community program seeks to have a positive, transforming impact on our people, the environment and our local community. The program has four pillars:

• Community Engagement: We support our local community through philanthropy, education and partnerships. Our employees have been at the forefront of these initiatives, and we’re proud of their contribution to making our community stronger.
• Environment and Sustainability: We are committed to being good stewards of the environment by aiming to ensure that our practices and processes are sustainable and responsible.
• Employee Engagement: We invest in our internal community through developing our employees, supporting their wellbeing and promoting an inclusive and diverse culture.
• Reconciliation: We’re exploring a pathway towards making a meaningful commitment to Reconciliation by strengthening our understanding and appreciation of Aboriginal and Torres Strait Islander peoples’ cultures, history and diversity.

Learn more about us:

Visit www.cookmedical.com.au/careers