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29

May

Regulatory Affairs Specialist

Integra LifeSciences - Clayton, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

relevant regulatory and medical device industry experience。

  • Prepare regulatory submissions and prostheses listings applications to facilitate product approvals in Australia and New Zealand
  • · Act as liaison with regulatory agencies, or other government departments related to regulation and reimbursement of medical devices.
  • · Effectively communicate with International Regulatory teams as well as Sales & Marketing, Customer Service, Warehouse and Technical Services
  • · Write and update departmental documented procedures in line with established Document Control processes.
  • · Keep up to date with regulatory requirements in Australia and New Zealand, and International requirements as applicable. This may include reading regulatory publications, relevant websites, and attending on and off site training.
  • 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.
  • Prepare TGA Annual post-market reports
  • Maintain currency and validity of Import Permits
  • Ensure collaborative relationships with Integra team members and external stakeholders.

relevant regulatory and medical device industry experience.

Bachelor degree, or appropriate qualifications, in allied health field such as biomedical engineering, sciences, nursing

Minimum 2 years knowledge and experience in regulatory affairs for medical devices 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

High level of experience with working autonomously and within a very small team environment.

Proven ability to take accountability for the quality and timeliness of their work outputs

Demonstrated ability to establish and maintain effective working relationship with co-workers, customers and other stakeholders.

High level of proactive problem solving skills

Demonstrated ability to maintain an excellent level of reporting, documentation and organisation.

Proficient computer literacy

Organisational Skills: Fully understand how this position interrelates to others. Understands impact of decisions on internal and external customers. Ability to initiate positive, effective changes based on a strong understanding of the process, the business and its customers. Ability to manage multiple projects successfully.

Clayton, VIC

Health, Medical & Pharmaceutical




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