Abbott Regulatory Affairs Specialist in Sydney, Australia
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An exciting opportunity has arisen for an experienced and enthusiastic Regulatory Affairs Associate. Reporting to the Senior QA & RA Associate, this position will assist with the preparation of regulatory submissions of company products to comply with Government Regulatory and Statutory legislation, manage expectations of commercial operations with the expectations of manufacturing and supply chain, and attend appropriate external seminars and educational sessions to keep abreast of Regulatory requirements to ensure the compliance of Abbott products and processes.
The main aspects of this role include:
Assist the Regulatory Affairs Department in the preparation and submission of applications (Class 1- 4) for registration of new products and variations to marketed products.
Assist in the review of scientific content of new registration packages to ensure they comply with government regulations prior to submission to the relevant Regulatory Authority.
Assist in the submission of Medical Incident reporting to relevant Regulatory Authority.
Work, communicate and support Regulatory Affairs effectively across many countries
Assist in the application of Import/Export Licenses and Permits for Applicable products.
Maintain good knowledge of the Therapeutic Goods Act,1989, with particular focus on the Australian Medical Devices regulations, and other relevant Federal and State Regulations.
Obtain and provide required documentation and regulatory advice for Tenders
In addition to the above, the relevant experience is required:
Computer literacy – experience in Microsoft Applications (Word, Excel, PowerPoint and Sharepoint)
Science degree or equivalent
Previous experience in dealing with BICON and New Zealand Ministry of Health applications an advantage.
Minimum 2 year Regulatory and experience within the diagnostics industry
Minimum 1 years' experience in a diagnostic laboratory setting
This role will work within a team of very capable and passionate individuals committed to getting the best outcomes for the patients and the customers that we serve.
Abbott provides some fantastic benefits for our employees, these include:
Discounted Shares program
Fresh fruit available to employees
AND…..Lots, lots more
To apply for this exciting opportunity, please visit our careers site at www.abbottcareers.com for more information
Abbott is an equal opportunity employer
We ask that recruiters respect our internal recruitment process and PSA panel, and refrain from contacting us, or referring candidates to this role.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org