Regulatory Affairs Specialist

4 days ago

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

Key Responsibilities

The successful Regulatory Affairs Associate will play a vital role in supporting on-market activities across various divisions. This is an exciting opportunity to work collaboratively with cross-functional teams and contribute to the development of regulatory strategies that drive business growth.

This role involves preparing and lodging regulatory submissions, including those requiring conformity assessments, for changes to on-market in vitro diagnostic (IVD) products and updates to internal compliance records. The candidate will review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding them to the appropriate national authority.

Main Aspects Of This Role Include:

  • Developing and implementing regulatory strategies that support on-market products
  • Preparing and lodging regulatory submissions, including those requiring conformity assessments
  • Reviewing and evaluating the scientific integrity of submission documents
  • Providing advice on local compliance needs to support innovation product maintenance requirements and/or modifications
  • Partnering with marketing to review and approve promotional content, ensuring adherence to local advertising regulations
  • Mentoring and training regulatory affairs colleagues, while leveraging data to identify and implement process improvements
  • Staying up-to-date with emerging regulations and communicating potential impacts to both local and global teams
  • Driving process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system
  • Sourcing additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS)
  • Providing timely regulatory intelligence and updates to leadership and cross-functional teams
  • Maintaining accurate regulatory documentation and records in accordance with internal procedures and regulatory requirements
  • Ensuring all regulatory decisions and activities are accurately documented
  • Prepared regulatory reports and summaries for internal and external stakeholders
  • Participating in cross-functional projects to meet regulatory and quality goals

Requirements

  • 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 both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR)
  • Familiarity with ISO 13485 and other relevant quality standards
  • Exceptional verbal, written, and interpersonal communication skills
  • Ability to work autonomously and collaboratively in a dynamic environment
  • Exceptional attention to detail across all regulatory and quality tasks
  • A mindset geared toward innovation and continuous improvement
  • Proactive engagement with industry trends and regulatory updates
  • Proven ability to manage multiple projects and competing priorities
  • Proficiency in Microsoft Office and other standard business applications

What We Offer

  • A collaborative team culture that values open communication, diversity, and shared learning
  • Ongoing opportunities for professional development and growth
  • Competitive salary and benefits package

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...

  • Regulatory Affairs Specialist

    4 days 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 Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to deliver regulatory submissions and maintain compliance.Deliver regulatory submissions on time;Ensure accurate company databases and systems by drafting, updating, reviewing and verifying entries;Maintain compliance with regulations and provide expert advice as...

  • Regulatory Affairs Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations and legislation.This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of...

  • Regulatory Affairs Specialist

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.Main Responsibilities:Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies...

  • Regulatory Affairs Specialist

    4 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Job Opportunity: Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to drive regulatory strategy and manage compliance in Australia and New Zealand.This role will involve monitoring legislative developments, providing advice and support to internal stakeholders on legal and regulatory matters, and operationalising regulatory...

  • Regulatory Affairs Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $80,000 - $120,000

    Regulatory Affairs SpecialistWe are seeking a skilled professional to support regulatory submissions and strategic projects across our diverse portfolio.About the RoleSupport regulatory submissions related to clinical trials, GMP, medicine shortages, and medical devices.Assist with data entry, documentation, and administrative tasks.Collaborate with internal...

  • Regulatory Affairs Specialist

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $125,000

    Job Title: Regulatory Affairs Specialist">Sydney Based Role:">We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team in Sydney. As a key member of our Asia business, you will be responsible for managing the regional and compliance frameworks of multiple products.">Key Responsibilities:">Determining requirements (local,...

  • Regulatory Affairs Specialist

    4 days ago

    Sydney, New South Wales, Australia Medella Life Full time

    Location- Sydney- Contact name:- Ethan Keating- Job ref:- 827- Published:- about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)****Location: Hybrid - Sydney, Australia****Key Responsibilities**:- **Regulatory Compliance**:- Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time

    Job Opportunity: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring the smooth flow of regulatory affairs activities and supporting the registration of new medicines in Australia.Key responsibilities include:Deliver regulatory submissions...