Regulatory Affairs Specialist - 12-Month Contract

The Opportunity:

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. 

Key Responsibilities include but are not limited to:

• Perform all tasks in accordance with the Quality Management System to a competent standard.
• Maintain design dossiers, technical files and other regulatory documents
• Maintain Regulatory Affairs project databases and systems which contain regulatory approval information
• Provide regulatory support on projects, as required
• Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
• Prepare device submissions for global markets for products manufactured in Australia
• Obtain export certificates and legalised documents for submissions 
• Review global marketing materials for compliance to relevant advertising guidelines
• Participate in internal quality audits
• Maintain our culture, values and commitment to Ethics and Compliance by recognizing, demonstrating, and enforcing appropriate and compliant behaviour

Key Requirements:

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

• 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 and ability to work in collaborative and independent work situations and environments with minimal supervision
• 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 

Employee Benefits:

• Flexible start/finish time and work location
• 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, prayer room and onsite parking
• Ongoing support, mentoring and professional development
• Inclusive team culture with opportunities to join our community engagement initiatives 

Please note only applicants that have full working rights within Australia are eligible to apply. Please apply with your CV and a cover letter outlining how you meet the requirements of the role. Shortlisting may commence immediately after advertisement posted.

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