Regulatory Affairs Associate

at  Abbott Laboratories

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.

EDUCATION

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

EXPERIENCE/BACKGROUND

• Minimum 3 years in a similar role
• In-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.

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