Regulatory Affairs Assistant
Aero Healthcare has a 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 Company’s regulatory affairs, Quality Management System and product compliance aspects.
- Act as an assistant to the Regulatory Officer for all Quality Management System tasks
- Inspection of products for release for sale, including coordinating with other departments such as Purchasing and Logistics
- Participate in internal and external audits
- Review technical, scientific and legal documents
- Ensure compliance with regulations set by the Therapeutic Goods Administration (TGA)
- Keep up to date with changes in regulatory legislation and guidelines
- Gather, evaluate, organise, manage and collate information in a variety of formats for review and approval by the Regulatory Officer
- Root cause analysis of customer complaints and quality deviations within corrective & preventive action framework
- Analyse complicated information, including sterilisation data/reports, risk management reports, clinical evaluation reports, etc.
- Negotiate with international and local suppliers to obtain information and documents to ensure ongoing product compliance
- Maintain familiarity with Company product ranges
- Attend to customer requests for product compliance documentation such as safety data sheets, product registration certificates, declarations of conformity, etc.
- Write comprehensible, user-friendly and clear Standard Operating Procedures for the Company to apply to day-to-day operations
- Meet deadlines and contribute to overall Company guidelines
- Previous Regulatory Affairs or Medical Devices experience
- 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 to fulfil all necessary requirements of this role
- Be an Australian resident and reside in Armidale, or be willing to relocate
The successful candidates will subscribe to our values of Accountability, Engagement, Responsibility and Openness 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 head of department
If this sounds like the role for you, please apply now.
The application form will include these questions:
- How many years’ experience do you have in a quality assurance (QA) role?
- How many years’ experience do you have in a quality control (QC) role?