Senior Regulatory Affairs Specialist

Sector

Manufacturing

QA


Type

Permanent / Full Time


Contact

info@onemd.com.au


Posted on

26 Apr 2022

Objective

A full time permanent position for a Global Medical Device company. Working in a team of 6 and working with Class I and Class IIb devices

Job Description

Our client is a global Medical Device organisation who are a household name across various specialty and product areas including: Vascular, Critical Care/ ICU, General Surgery, Diabetes, Diagnostics etc.
They offer fantastic training and onboarding and there are plenty of opportunities for career development and progression within the organisation.

Position Overview:

This position has been newly developed within the Q'land General Surgery team and has a Brisbane territory focus. The role is theatre based but with no 'on call' and overall, a much better work/ life balance compared but certain clinical roles within devices.

Responsibilities:
  • Responsible for planning, organizing, leading and conducting duties related to the site’s regulatory obligations including
  • Implementation of new regulations
  • Lead the development of plans and get stakeholder and management buy-in to implement regulations that have a significant impact on the business (e.g. IVDR, UDI, Diagnostics
  • Lead global regulatory strategy for new products and significant product changes
  • Work with global colleagues in support of complex class I and higher class product registrations and submission
Experience required:
  • Bachelor’s degree preferably in science, medical or engineering.
  • Minimum 5 years Regulatory Affairs experience in medical devices required, IVD instruments experience highly desirable.
  • Demonstrated experience in:
    • Creating global regulatory strategy for new product development and product lifecycle.
    • Vigilance and post-market surveillance.
    • Subject matter expert during regulatory audits.
  • Lead assessment and implementation of complex regulations
What's on offer:
  • Base salary of $129,000 per annum plus super 
  • 10% Bonus 
  • Full time permanent role 
  • Flexible hybrid working arrangements 
  • Senior role with in the Company 
 To apply for this role, please reach out to Nicola Davison on 0472 729 731

nicola.davison@onemd.com.au

Requirements

  • Full time permanent position
  • Complete work from home flexibility
  • Senior role within the company