Current jobs related to Regulatory Affairs Professional - Sydney, New South Wales - beBeeRegulatory

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with regulatory requirements and contributing to the development and implementation of regulatory strategies.The ideal candidate will have a strong...

  • Regulatory Affairs Professional

    1 week ago

    Sydney, New South Wales, Australia beBeeregulatory Full time $115,000 - $145,000

    Job Opportunity:This position is ideal for professionals who are passionate about developing innovative products and supplements.About the Role:We have an exciting opportunity for a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will drive excellence in regulatory affairs and contribute to...

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $125,000 - $165,000

    Regulatory Affairs SpecialistA key member of our team, the Regulatory Affairs Specialist is accountable for providing regulatory affairs knowledge and support to ensure our business meets its objectives.Delivering product pre-market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities requires dedication...

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $61,998 - $135,122

    As a Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance with medical device regulations and facilitating the commercialization of products in the Australia and New Zealand (ANZ) region.The successful candidate will possess strong analytical skills, excellent written and verbal communication skills, and the ability to work...

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $160,000 - $200,000

    Job Title: Regulatory Affairs ProfessionalThe role of a Regulatory Affairs Professional involves leading external engagements with domestic and international counterparts and government.Contribute to policy work, as it relates to the operating environment;Partner with teams across the organization to deliver desired outcomes;Brief senior executives on...

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000

    About the Job">This is a highly specialized role requiring expertise in regulatory affairs within the medical device industry.The successful candidate will play a key part in developing and executing regulatory strategies to ensure compliance with local and international regulations.Key responsibilities include managing product registrations, maintaining...

  • Regulatory Affairs Professional

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $150,000

    **Job Role Overview:**We are seeking a highly skilled Regulatory Affairs Associate to join our team.**Key Responsibilities Include:Maintaining accurate and up-to-date regulatory records for assigned product portfolios in compliance with local and global procedures.

  • Regulatory Affairs Associate

    1 week ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs AssociateCategory:Reg Affairs & Safety PharmacovigilanceLocation:North Sydney, New South Wales, AURegulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaAre you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive in a dynamic and...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Job SummaryClinical professionals looking to develop their expertise in regulatory affairs will find this role a stimulating challenge. We seek a detail-oriented and highly motivated Regulatory Affairs Specialist to support our team.Key Responsibilities:Support the preparation and submission of regulatory documents.Maintain accurate records and provide...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs Associate**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:North Sydney, New South Wales, AU**Regulatory Affairs Associate****Clinical, Medical & Regulatory (CMR)****Sydney, Australia**- Are you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive...

Regulatory Affairs Professional

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time
Regulatory Affairs Role Overview

This exciting opportunity has arisen for a motivated and proactive Regulatory Affairs Associate to support on-market activities. The role is ideal for candidates with foundational experience in regulatory affairs for medical devices/in vitro diagnostics.

The successful candidate will provide wide-ranging support across the regulatory department, collaborating closely with cross-functional teams including marketing, sales, and logistics to develop regulatory strategies that support on-market products.

  • Prepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on-market in vitro diagnostic (IVD) products and updates to internal compliance records.
  • Review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.
  • Advise global regulatory on-market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.
  • Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.

The ideal candidate will have a solid understanding of both Australian and international regulatory frameworks, excellent verbal, written, and interpersonal communication skills, and the ability to work autonomously and collaboratively in a dynamic environment.

Key Responsibilities:
  • Collaborate with cross-functional teams to develop regulatory strategies.
  • Prepare and lodge regulatory submissions.
  • Review and evaluate submission documents.
  • Advise global regulatory on-market teams.
  • Participate in cross-functional projects.
Required Skills and Qualifications:
  • A degree in science, biomedical studies, or a related field.
  • At least 2–3 years of experience in regulatory affairs within the medical device or IVD sector.
  • Solid understanding of Australian and international regulatory frameworks.
  • Familiarity with ISO 13485 and other relevant quality standards.
What We Offer:

Full-time employment in a dynamic environment with opportunities for growth and development.

Benefits:

Competitive salary and benefits package.