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May

Regulatory Affairs Associate

Pettit Pharma & Device Search | Healthcare Recruitment - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

WHAT THIS COMPANY DOES

  • This company is a global leader in medical technology and they are dedicated to providing surgeons with certainty, so they can concentrate on providing the best possible patient care.
  • They are a leader in their field, offering a broad portfolio of medical implants and devices.


WHAT’S GREAT ABOUT WORKING WITH THIS ORGANISATION

  • They make things happen for their customers and in turn they build careers for their people.
  • With a global team dedicated to improving patient outcomes, this organisation can provide you with a purpose and professional growth to take you to the next level of your career.


THE ROLE – WHAT YOU WILL BE RESPONSIBLE FOR

  • This Regulatory Affairs Specialist position is responsible for delivering high quality and timely support services to the Regulatory Affairs and Prostheses Listing functions and, where required, delivering support services related to the Quality Management function.
  • The role will prepare regulatory submissions and prostheses list applications to facilitate product approvals in Australia and New Zealand.
  • The position will act as liaison with regulatory agencies, or other government departments, related to regulation and reimbursement of medical devices.
  • You will communicate with international regulatory teams as well as sales & marketing, customer service, warehouse and technical services.
  • You will keep up to date with regulatory requirements in Australia and New Zealand, and review regulatory publications, relevant websites and attend on and off-site training.
  • You will participate in global regulatory projects. This may require capacity to dial-in for teleconferences outside of standard working hours from time to time.
  • You will assist in coordinating and conducting recall actions and report complaints to manufacturers and to the TGA and Medsafe as required, including liaising with sales staff and customers to gather relevant information for complaint investigation and facilitate product credits and replacements.
  • You will prepare TGA annual post-market reports and maintain currency and validity of import permits and process TGA fees and charges, prepare TGA charges exemption applications and related documentation for exemption validation reviews by TGA.


WHAT YOU WILL NEED TO BE SUCCESSFUL IN THE ROLE

  • Bachelor degree, or appropriate qualifications, in allied health field such as biomedical engineering, sciences, nursing.
  • Minimum 2 years knowledge and experience in regulatory affairs in the medical device industry in Australia.
  • Experience in device applications to the TGA including responding to questions, liaising with manufacturers; complaint handling and recall action implementation and coordination.
  • Experience working within a quality management system, preferably in an ISO 13485 certified environment.


Interested? Please apply now quoting reference number 3129 or call Scott Della-Pietra on 02.8310.9266. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.

Melbourne, VIC

Health, Medical & Pharmaceutical




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