Regulatory Affairs Associate

4 days ago


Sydney, Australia HAYS Full time

An exciting opportunity to work for a medical device company in Sydney

**Your new company**

A market leading medical device company based in Sydney

**Your new role**

You will be responsible for preparing and submitting medical devices registrations as well as maintaining compliance in accordance to the medical device regulatory requirements and standards applicable to Australia and New Zealand. You will be responsible for ensuring that all documentation and databases such as technical files and certifications are kept up to date. Submit. Implement and maintain pre-market and post market strategy in line with regulatory guidelines. Lead and support internal and external audits and manage relevant stakeholders be able to work cross functionally with quality and operations as required.

**What you'll need to succeed**

Tertiary qualified in science related field

Experience in medical devices

Knowledge of medical device regulations

Excellent communication skills

**What you'll get in return**

You will get flexibility and the opportunity to work on exciting devices that support patients in Australia.

**What you need to do now**

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

**LHS 297508**#2782228



  • Sydney, Australia Bausch + Lomb Full time

    REGULATORY AFFAIRS ASSOCIATE - Fixed Term Control Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to...


  • Sydney, Australia Pfizer Full time

    Why Patients Need You This is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for...


  • Sydney, Australia Viatris Full time

    3801 Upjohn Australia Pty Ltd. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines...


  • Sydney, Australia Sandoz Full time

    5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Join the Team of the Year at Sandoz ANZ where you can actively contribute to this number by managing and maintaining current GMP for existing and new manufacturing sites to support supply...


  • Sydney, Australia OneMD Pty Ltd Full time

    Working with Class III consumbale devices - Can be located in any major city across Australia - Excellent company for career progression Our client is one of Australia’s leading independent medical device distributors. They are growing at a rapid rate after strategic acquisitions across the globe. Which in turn means a strong pipeline of new products....


  • Sydney, Australia Coadys Personnel Full time

    Our client is a successful and rapidly expanding pharmaceutical manufacturing organisation. With a large team of around 70 staff, this position will be responsible for ensuring all regulatory activities for the business and it's customers adhere to the requirements of regulatory bodies and company standards. Working closely with internal teams (QA, Sales,...


  • Sydney, Australia Pfizer Full time

    Use Your Power for Purpose We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized...


  • Sydney, Australia Goodman Full time

    Advisory role working across multiple food categories - Autonomous role - ability to make the role your own! - Macquarie Park based with WFH 2 days a week At Goodman Fielder our purpose is making everyday food better for everyone. Our aspiration is to be the leading integrated food solutions business in the region. We are a team that believes that anything...


  • Council of the City of Sydney, Australia DBG Health Pty Full time

    We are seeking a Senior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team. About the Company DBG Health & Arrotex Pharmaceuticals: DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable...


  • Sydney, Australia Australian Prudential Regulation Authority (APRA) Full time

    **The role** **The team** APRA’s Regulatory Affairs team sits within the Chief of Staff and Enterprise Services Division alongside APRA’s Corporate Affairs, Strategy & Governance, Finance, People & Culture, and Operations functions. Our Regulatory Affairs team leads APRA’s domestic engagement (e.g. liaison with ASIC, RBA, Treasury, AUSTRAC and...