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Regulatory Affairs Associate

Abbott - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin


An exciting opportunity has arisen for a Regulatory Affairs Associate to join our team on a 12 month fixed-term contract, 3 days per week. This exciting roll will provide Regulatory Affairs support to our Medical Device business units at Abbott

Reporting to the Regulatory Affairs Director, you will be based in our head office at Macquarie Park and drive activities relating to maintenance of Australian regulatory approvals during the transition to EU Medical Device Regulations (MDR).

Your Core Responsibilities Include

  • Identifying, preparing and submitting EU MDR related Therapeutic Goods Administration and/or Medsafe applications
  • Managing updates and maintenance of our internal records and systems to facilitate release of appropriate product
  • Assisting with responses to deficiency letters and other requests for data
  • Monitoring progress of applications through the regulatory system
  • Providing regulatory support for medical, marketing and other corporate functions as required
  • Assisting with other Regulatory projects and activities as required

/Experience Required
  • Bachelor’s degree in a scientific discipline equivalent: Bachelor’s degree in bio medical /medical technology/science preferred.
  • 12 months experience in an Australian medical device regulatory role is advantageous.
What sets you apart?
  • Excellent attention to detail
  • Good Computer Literacy required for Word, Excel and Powerpoint
  • Attention to detail
  • Well-developed written and verbal communication skills
  • Collaborative approach to teamwork
Abbott provides some fantastic benefits for our employees, these include:
  • Free parking, onsite gym and Barista at our Macquarie Park office
  • Discounted Healthcare
  • Discounted Shares program
  • Wellness Programs
  • Professional and Personal development opportunities
  • AND…..Lots, lots more
To apply for this exciting opportunity, please visit our careers site at www.abbottcareers.com for more information.

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 109,000 colleagues serve people in more than 160 countries.

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.

Sydney, NSW

Health, Medical & Pharmaceutical


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