Abbott
 

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
 

Working at Abbott
 

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
 

•              Career development with an international company where you can grow the career you dream of .

•              Amazing health and wellness benefits and perks.

•              A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

•              A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

This position works for Corelab. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
 

Main purpose of the role
 

•              Professional individual contributor that is fully proficient in applying established standards.

•              Knowledge base acquired from 3+ years of experience in Regulatory Affairs.

•              Works independently.

•              May instruct or coach other professionals in regulatory requirements.
 

Main responsibilities
 

•              A professional RA Associate in the Regulatory Affairs Department possessing advanced knowledge in product registration submission for all Classes of IVD products including TGA Conformity Assessment.

Developing strategies for product registration to support commercial product launch with other business stakeholders such as marketing, sales, logistics.Reviewing the scientific content of registration packages to ensure they comply with government regulations prior to submission to the relevant country Regulatory Authority.Providing input to global regulatory and R&D teams on local requirements to facilitate new product development or product changes.Collaborating with marketing to review and approve advertising and promotional material to ensure it complies with local regulatory requirements.Maintaining good knowledge of the ISO9001 Standard and the Therapeutic Goods Act 1989, with particular focus on the Australian Medical Devices Regulations 2002, and other relevant Federal and State Regulations.Supporting RA team with submission of local Medical Incident reporting to relevant country Regulatory Authority.Participate in industry forums, conferences, and working groups to influence regulatory policies and standards.Monitoring and assessing changes to emerging regulations and communicating the impact of these changes to the wider organisation, locally and globally.Stay current with global regulatory trends, guidance documents, and industry best practices.Creating and implementing any process changes required as a result of these changes and working with Quality Assurance to ensure regulatory requirements are met and integrated into the Quality system.Obtaining any additional authorisations to support business needs e.g. import permits, Certificates of Free Sale (CFS).Foster a collaborative and inclusive team environment, encouraging open communication and knowledge sharing

Qualifications
 

Education

•              Bachelor's degree in science/ biomedical science/Biochemical Engineering/ Biochemistry

Experience/Background

Minimum 3 years in a similar roleIn-depth knowledge of Australian and international regulatory requirements (e.g., TGA, FDA, EU MDR/IVDR).Experience with ISO 13485 and other relevant quality standards.Strong analytical, organizational, and communication skills.Question the status quo and propose innovative solutions to regulatory and quality challenges.Ability to work in both a Team environment and independently, high attention to detail and ability to prioritize is essential.Demonstrate high attention to detail in all regulatory and quality activities.