Regulatory Affairs Associate

2 weeks ago

Sydney, New South Wales, Australia Programmed Full time
  • Looking for a Regulatory Affairs Associate
  • Competitive remuneration package
  • 12 Months Max terms contract role with high potential of getting extended.

About the company:

PERSOLKELLY brings together the legacy and experience of four organizations that shaped the staffing landscape over the past century: Kelly Services, who pioneered the modern temporary help industry in 1946; SKILLED, who crafted the staffing industry in Australia in 1964; Programmed, the leading provider of operations and maintenance services across Australia and New Zealand; and PERSOLKELLY, the largest workforce solutions provider in APAC.

About the client:

Since our start in 1902, 3M has evolved into a global powerhouse driven by science, innovation, and integrity. With sales in approximately 200 countries, all our 96,000 employees are dedicated to science and exploration - driving to understand our customers' needs. We strive to solve today's challenges and prepare for the future, aiming to create a more positive world through science by delivering innovative solutions that add value for our customers. Our impact spans markets - and today, you are never more than three meters away from 3M technology working to improve your life. We use our 51 technology platforms to apply science in the right ways to create products and solutions that deliver value to society - from advanced health care, personal safety, and industrial abrasives to traffic safety, food safety, commercial solutions, and more.

About the Role:

Supports transition of Health Care Business products for ANZ to new legal entity. Develops and maintains documentation relevant to assessment of risk to human health and the environment. Prepares and files regulatory documents. Updates internal database registries in alignment with product portfolios.

Business support for:

  • Product registration
  • Post market product activity compliance

Business support including:

  • Review promotional activities
  • Review Artwork/ Packaging materials supporting compliance and registration of product

Pursues continuing education efforts to develop advanced knowledge of regulatory requirements, in consumer healthcare regulations, product responsibility skills and knowledge, and business, including an understanding of technologies applicable to the job requirements.

To succeed in this role, the successful candidate should meet the following criteria:

  • Knowledge of all aspects of medical device regulatory compliance.
  • Develops a broad knowledge and understanding of the technical, manufacturing, sales and marketing functions and interfaces.
  • Establishes and cultivates a network of support, such as technical, health care regulatory, manufacturing, sales, marketing, legal, corporate regulatory and EHS staff internally and regulators and industry associations externally. Multinational global interactions are required.
  • Knowldege of various Microsoft software.
  • Excellent attention to detail.
  • Good written and verbal communication skills.
  • Strong interpersonal skills particularly in facilitating and influencing.
  • Able to focus and work to achieve business priorities by utilising good organisation and planning skills
  • Essential: Graduate qualifications in science.
  • Desirable: Background in health sciences, Background in business.

How to Apply:

This role offers you an exciting opportunity to join a diverse team within a highly successful organization. If you are ready for a change and wish to be part of a fast-paced team where you can make a difference, then we would be interested to hear from you.If you are interested, please click 'APPLY' or contact Prasanth Natesan, Recruitment Consultant on for a confidential discussion.

Who are we

At PERSOLKELLY, our passion is - and always has been - putting you first.

We propel our people forward by supporting their careers in fresh ways, backed by our expertise and capability.

We're committed to creating a safe and inclusive environment which values and respects diverse styles, backgrounds, experience and perspectives.

We welcome and encourage women, people of Aboriginal and Torres Strait Islander descent and people from diverse backgrounds to apply.

So it's over to you. If you would like to join our team, please APPLY now.

To learn more about working with PERSOLKELLY, we encourage you to visit our website.

Follow our LinkedIn page at for the latest updates and insights.

Consultant

Ekta Ojha

Reference number: _
Profession:ScienceQA & QC

Company: Programmed
Date posted: 7th Jun, 2024

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