Global Regulatory Affairs Professional

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $115,000 - $125,000
Senior Associate – Global Regulatory Affairs Job Opportunity

This is a rare chance to be part of a purpose-driven organisation as it transitions into a world-class, quality-led medical device company with a global presence.

About the Role

In this Senior Associate – Global Regulatory Affairs & Quality position, you will play a key role in post-market quality and regulatory operations, supporting compliance, continuous improvement, and robust product lifecycle management.

You will lead complaint handling and vigilance processes, develop post-market systems, and ensure alignment with ISO 13485, TGA, and international regulatory standards.

Key Responsibilities:

  • Manage global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing.
  • Develop and implement a centralised post-market surveillance process, including migration into a new eQMS system.
  • Analyse and trend post-market data to support continuous improvement and risk mitigation initiatives.
  • Liaise with internal and external stakeholders globally to ensure alignment and quality communication.
  • Support internal and external audits, staff training, and development of controlled quality documentation.
  • Contribute to the development and maintenance of global procedures and metrics.

About You

  1. Minimum 5 years' experience in quality and regulatory affairs within the medical device sector.
  2. Proven experience managing post-market surveillance, complaint handling, and vigilance reporting.
  3. Strong understanding of ISO 13485, TGA, FDA, MDR and quality systems principles.
  4. Demonstrated ability to work cross-functionally across regions (e.g. Operations, R&D, Sales & Marketing).
  5. Hands-on experience with eQMS platforms highly regarded.
  6. Excellent problem-solving, communication, and data analysis skills.
  7. Degree in Life Sciences, Engineering or related discipline (equivalent experience considered).

  • Regulatory Affairs Professional

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $105,000

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our organization, you will play a crucial role in ensuring the continuity of supply via lifecycle maintenance activities for our existing portfolio and supporting the registration of new medicines in Australia.Compliance with local and global...

  • Global Regulatory Affairs Quality Specialist

    20 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000

    Job Opportunity:Senior Associate – Global Regulatory AffairsWe are seeking a highly skilled Senior Associate to join our global regulatory affairs and quality team. As a key member of this team, you will play a vital role in post-market quality and regulatory operations.Manage global post-market activities including complaint handling, vigilance reporting,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $120,000 - $205,000

    Job Title: Regulatory Affairs SpecialistOur organization seeks an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will possess a deep understanding of global regulations and standards, with a proven track record of developing and implementing effective regulatory strategies.About the Role:The Regulatory Affairs Specialist will...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    Regulatory Affairs Manager | Rare Disease | SYDJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Regulatory Affairs Manager | Rare Disease | SYD1 day ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Get AI-powered advice on this job and...

  • Regulatory Affairs Manager

    4 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    Regulatory Affairs Manager | Rare Disease | SYDJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & HurstRegulatory Affairs Manager | Rare Disease | SYD1 day ago Be among the first 25 applicantsJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & HurstGet AI-powered advice on this job and more...

  • Regulatory Affairs Manager

    4 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    Regulatory Affairs Manager | Rare Disease | SYDJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & HurstRegulatory Affairs Manager | Rare Disease | SYD1 day ago Be among the first 25 applicantsJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & HurstGet AI-powered advice on this job and more...

  • Senior Associate – Global Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Proclinical Staffing Full time

    Senior Associate – Global Regulatory Affairs & Quality Senior Associate – Global Regulatory Affairs & Quality Get AI-powered advice on this job and more exclusive features.This range is provided by Proclinical Staffing.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range A$115,000.00/yr -...

  • Regulatory Affairs Professional

    18 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $97,000 - $118,000

    About the RoleThis is a regulatory affairs associate role that plays a critical part in ensuring the continuity of supply through life cycle maintenance activities for our existing portfolio and supporting the registration of new medicines.The ideal candidate will have experience in regulatory affairs, preferably with prescription medicines, and an...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...