Regulatory Scientist

Permanent position, excellent benefits, work from home 1-3 days a week

Contribute to positive patient outcomes, what a great reason to come to work!

Diverse and inclusive culture

Are you seeking variety in your role?  Do you have an interest in medical devices? 

Reporting to the Team Lead – Regulatory Affairs this role is responsible for the effective execution of the post-market surveillance activities for Cook Australia devices with a high focus on quality.

• Plan and lead cross-functional post-market surveillance meetings for each of the WCA medical device families.
• Analyse post-market data for inclusion into reports, liaise with different stakeholders, and dissemination to the Cook Australia management team.
• Independently prepare and submit annual post-market surveillance plans and reports according to regulatory requirements (e.g., European, Canadian, and Chinese Medical Device Regulations).
• Provide input and review of periodic FDA reports for PMA and investigational devices.
• Conduct clinical evaluation in compliance with European and Australian regulatory requirements.
• Perform all tasks in accordance with the ISO 13485 Quality Management System.

• Tertiary qualification in either science, engineering, or pharmacy essential, and a minimum of 3 years of prior relevant experience.
• Experience within medical device or pharmaceutical industry desirable.
• Exposure to the European Medical Device Regulations (EU MDR), particularly in areas of regulatory affairs, post-market surveillance, or risk management is desirable.
• Strong MS Excel skills with experience in statistical data visualization and business intelligence software.
• Experience in medical writing.
• Experience in systematic review and clinical data appraisal is desirable.
• Experience managing projects is desirable.

Cook Can Offer:

• Option to work from home 1-3 days a week (remote work may be considered for ideal candidate)
• Stability of a long-established company
• Values recognition and service awards
• Base salary plus quarterly paid bonuses
• Annual Leave Loading
• Subsidised cafeteria & onsite parking
• Ongoing support, training, and development
• Strong inclusive culture that values our people

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. 

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