Regulatory Affairs Assistant
Aero Healthcare has the vision to be the accepted global leader in the first aid and consumer wound care sector, manufacturing products that deliver superior outcomes and generate strong brand loyalty. Our brand is trusted and respected both in Australia and Internationally. We are currently seeking a Regulatory Affairs Assistant to join our Armidale team.
This role involves being responsible for the companies’ regulatory affairs, Quality Management System and product compliance aspects
- Act as an assistant to the Regulatory Officer for all Quality Management System tasks.
- Studying scientific and legal documents
- Gathering, evaluating, organising, managing and collating information in a variety of formats for review and approval by the Regulatory Officer.
- Completes paperwork and correspondence required to maintain the function of the quality system.
- Ensuring compliance with regulations set by the Therapeutic Goods Administration (TGA)
- Maintaining familiarity with company product ranges
- Keeping up to date with changes in regulatory legislation and guidelines
- Analysing complicated information, including sterilization data/reports, Risk Management data of the produce/process, clinical evaluation data/reports, etc.
- Verification of product for release for sale
- Writing comprehensible, user-friendly, clear Standard Operating Procedures for Company
- Assist the Regulatory Officer with internal audits.
- Undertake all regulatory processes throughout the entire product life-cycle.
- Meet deadlines and contribute to overall company guidelines
- Analytical skills
- Time management skills
- Problem-solving skills
- Presentation skills
- Excellent Interpersonal skills
- Communication skills
- A Bachelor of Science or relevant degree (beneficial but not essential).
- Knowledge of national and international medical device regulatory requirements, or be willing to upskill
- Good attention to detail and accuracy
- Ability to follow instructions
- Be willing to undergo training to gain the required skills in any areas lacking experience
- Be an Australian resident and reside in Armidale, or be willing to relocate
The successful candidates will subscribe to our values of Integrity, Professionalism, Innovation and Energy and possess the skills to work effectively in a small team and will be reliable, punctual and enthusiastic.
- The opportunity to work for a successful and international company.
- An excellent work environment and supportive management
- Ongoing role with opportunity to progress into a global position.
If this sounds like the role for you please apply now.