Senior Regulatory Scientist

Reporting to the Team Lead, Regulatory Affairs, you will bring yourexperience in research, data analysis, and scientific communication to our dynamic and collaborative Regulatory Affairs team. In this role, you will be responsible for conducting thorough  clinical literature reviews and preparing Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) reports for medical devices in the vascular and reproductive health fields. You will also contribute to the development of clinical strategies, support audits, and foster a culture of compliance and process improvement.

• Independently conduct reviews of clinical literature and develop documentation to support safety and performance of medical devices, in accordance to EU MDR, Australian regulatory requirements (TGA) and other relevant industry standards.
• Appraise clinical data and provide regulatory input throughout all project phases, including developing clinical strategies, clinical evaluation plans, evaluating clinical evidence.
• Reviewing and substantiating marketing claims through clinical evidence to ensure suitability for regulatory submissions.
• Contribute to the development of strategies for ongoing post-market surveillance.
• Work with cross-functional teams, including Engineering, Quality Assurance, Marketing, and R&D, to ensure alignment of clinical evaluation activities and strategies when required.
• With limited supervision, prepare and review clear, comprehensive procedures for clinical evaluation and post-market surveillance.
• Maintain knowledge and disseminate regulatory updates applicable to clinical evaluation and post-market surveillance.

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 qualifications in Science, Engineering, Pharmacy, or Microbiology is essential
• Industry experience in research methodology, information management, and medical writing is essential
• Experience working in a highly regulated industry such as medical devices, ISO 13485 principles is essential
• Experience in effectively and accurately communicating technical medical and scientific information to persons without expertise in the subject area

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, prayer room and onsite parking
• Ongoing support, mentoring and professional development
• Inclusive team culture with opportunities to join our community engagement initiatives

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, whether we service patients, customers or colleagues, we all share a culture and a set of core values.  The reflection of Cook’s seven values in our daily business activities is an expectation of us all.  By acting with integrity, being transparent and treating everyone with respect we can truly collaborate and be open to different ideas and perspectives.

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