Careers

Regulatory Compliance Associate - part time

  • Regulatory and Compliance Associate experienced across a wide area of business compliance

  • Flexible Part-time role, 3 days a week in the veterinary and medical diagnostics industry

  • Melbourne based opportunity to contribute to the continued success of AsureQuality Diagnostics

The Opportunity:

This is your opportunity to be the key regulatory and compliance lead who continues building our quality and compliance culture and ensures AsureQuality Diagnostics' compliance with all regulatory, legislative and operational licencing commitments.

Responsibilities include maintaining our existing product registrations, submitting new product registrations, managing import and export permits, maintaining our poisons license and Biosecurity Approved Arrangement and enabling our H&S agenda.

Your regulatory and compliance knowledge will enable you to provide regulatory guidance to the business and our customers and develop systems and processes to future proof our operations. You will also have the opportunity to work with the Quality Team and apply your auditing skills to support compliance with GMP and certification requirements (ISO, APVMA).

This is a time for real growth and personal development in a small and diverse team who are experts in their fields. There is a real team camaraderie as everyone contributes to each other's success to support our continued and sustainable business growth.

Do you see this as your next career step? If so apply today!

About You:

To hit the ground running in this role, you will ideally have

  • Bachelor of Science or tertiary equivalent.

  • Previous experience working in Regulatory Affairs including regulatory submissions and permit applications (APVMA, Biosecurity, MPI, ACVM, Dept of Health).

  • Experience working in regulated environments such as, APVMA, TGA, FDA, ISO 9001, ISO 13485.

  • Previous QA experience in a GMP environment and exposure to H&S systems (WorkSafe) would be highly regarded.

  • Technical writing skills, particularly authorship of SOPs and development of training programmes.

  • Strong organisational skills and the ability to work systemically to achieve high Quality standards

  • Self-motivation, a positive outlook and the drive to focus on solutions while understanding the balance between risks, benefits and customer requirements in decision making

A background in Medical or Veterinary Diagnostics or Pharmaceutical manufacture will be looked upon favourably, as will qualifications in training and/or auditing.

To apply to this role, please click the link and include a CV and Cover Letter which will outline your skills and experience, in relation to the details and values outlined above.

We wish you the best of luck

About Us:

AsureQuality Diagnostics is a leading contract manufacturer and distributor of veterinary and medical diagnostic kits and speciality products. Our expertise lies in developing solutions for customers worldwide and producing goods to strict GMP quality standards. Our customers are working in scientific research, food analysis, biotechnology, veterinary and human diagnostic industries. We are part of AsureQuality Ltd, a New Zealand based company with a solid reputation for delivering expert services and value to a range of sectors.

 

Job Details

Reference #48036

Posted on 05 May 2022

Closes on 26 May 2022 23:55

Location(s) Victoria

Expertise Quality Assurance

Job level(s) Experienced

Work type(s) Permanent Part time

More details (document) PD - Regulatory & Compliance Associate - May 2022.pdf

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