Quality and Regulatory Affairs Associate

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    23 hours ago
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**Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.**

An exciting opportunity has come up for a motivated Quality and Regulatory associate to join our Diagnostics division on fixed term contract for 24 months with a possibility of extension. Based at our head office in Macquarie park, this role would require you to work with a close-knit team that’s consistently working towards providing insights that enable smarter, faster decisions and transform the way the world is managing health.

**The main aspects of this role include:**

+ Assisting the Regulatory Affairs Department in the preparation and submission of applications (IVDs and some MD) for registration of new products and variations to marketed products, including conformity assessed products

+ Supporting the team in the review of scientific content of new registration packages to ensure they comply with government regulations prior to submission to the relevant country Regulatory Authority and assisting in the submission of Medical Incident reporting to relevant country Regulatory Authority

+ Maintaining good knowledge of the ISO9001 Standard and the Therapeutic Goods Act,1989, with particular focus on the Australian Medical Devices regulations, and other relevant Federal and State Regulations.

+ Review and approval of Advertising and Promotional material

+ Obtaining and providing required documentation and regulatory advice for Tenders

+ Assisting in the application of Import/Export Licenses and Permits for applicable products

+ Managing Quality Management System activities, including internal auditing, management review, CAPA, training, supplier qualification and management

+ Co-ordinating and implementing product action (e.g., Field Actions, Product Information, Quality Holds etc.)

+ Preparing and maintaining key KPIs for the Management Systems

+ Advocating for Quality and Compliance within the Abbott organization and provide advice on Quality related matters to all functional areas

+ Training of internal customers in all aspects of Regulatory and Quality requirements.

**What would make you a successful candidate for this role:**

You will be self-motivated with a strong work ethic and pay excellent attention to detail. In order to succeed you will also possess the following:

+ Degree in Science, pharmacy or equivalent

+ Minimum 1-2 years Regulatory and/or Quality experience within the medical devices industry

+ Experience and knowledge of ISO9001

+ Exceptional communication skills (verbal/written/presentation/relationship building) and the ability to work collaboratively with customers, internal stakeholders and regulators. 

**Abbott provides some fantastic benefits for our employees, these include:**

+ Free Parking

+ Onsite Gym

+ Mothers Room

+ Discounted Healthcare

+ Discounted Shares program

+ Wellness program that includes Fresh fruit etc.

+ Easy access to public transport, bus and rail

+ AND…..Lots, lots more

To apply for this exciting opportunity, please visit our careers site at www.abbottcareers.com for more information.

**Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.**

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 corpjat@abbott.com