Expert Regulatory Affairs Professional

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $135,000 - $155,000

Job Title: Regulatory Affairs Expert

Job Description:

We are seeking a highly skilled Regulatory Affairs professional to join our team on a short-term, part-time basis during a critical period.

As a Regulatory Affairs expert in the post-market regulatory field, you will work across various activities to ensure compliance for our marketed medical devices.

The ideal candidate will have experience with post-market regulatory activities, including representation on cross-functional teams and preparation of regulatory assessments.

You will also support medical device reporting and post-market surveillance activities, monitor updates to global regulatory standards, and assist with special projects to support business continuity and compliance.

  • Represent Regulatory Affairs on selected post-market cross-functional teams
  • Prepare and implement post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies)
  • Support medical device reporting (MDR) and post-market surveillance activities
  • Monitor updates to global regulatory standards (FDA, EU MDR, ISO, IEC) and ensure alignment
  • Assist with special projects to support business continuity and compliance
Required Skills and Qualifications:
  • A degree in Engineering, Science, or a related field
  • 6+ years' experience in medical device regulatory affairs
  • Hands-on experience with post-market regulatory activities
  • Excellent documentation, organizational, and stakeholder communication skills
  • Comfortable working independently in a flexible, part-time consultancy model
Benefits:

We offer a dynamic and supportive work environment, competitive compensation, and opportunities for growth and development.

What We Offer:

If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to submit your application today.

  • Expert Regulatory Affairs Professional

    2 days ago

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

    Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs professional to join our team. As an Advisor, you will lead engagement across APRA to ensure our external regulatory relationships are supported by relevant subject matter expertise.The successful candidate will work on a broad range of diverse issues that are important to...

  • Regulatory Affairs Expert

    3 days ago

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

    Regulatory Affairs Expert | Rare Disease SpecialistThe role of Regulatory Affairs Expert is pivotal in the development, approval, and lifecycle management of innovative medicines. This global position offers a unique opportunity to take full ownership of regulatory affairs across ANZ.Develop and execute strategic regulatory submission plans to support new...

  • Regulatory Affairs Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Regulatory Affairs LeadAbout the Position:The Regulatory Affairs Lead plays a critical role in driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This individual will bridge strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and...

  • Regulatory Affairs Expert

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairsLead Full time $200,000 - $250,000

    Regulatory Affairs Lead Job DescriptionThe Regulatory Affairs Lead plays a pivotal role in ensuring compliance with regulatory requirements and driving key activities for the organization.Job Responsibilities:Strategic Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market...

  • Expert Regulatory Affairs Professional

    5 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $160,000

    Regulatory Affairs Role OverviewThe Regulatory Affairs Specialist is responsible for ensuring compliance with healthcare industry regulatory requirements.Key Responsibilities:Develops and implements strategies to support business objectives by staying up-to-date on global regulatory bodies and best practices.Collaborates with cross-functional teams to ensure...

  • Regulatory Affairs Professional

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $90,000

    Job OpportunityWe are seeking an experienced professional to join our team in a regulatory affairs capacity.Main Responsibilities:To manage and maintain accurate company databases and systems by drafting, updating, reviewing and verifying entries;To ensure compliance with relevant regulations and codes and provide expert advice to personnel as required;To...

  • Regulatory Affairs Professional

    4 days ago

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

    About Regulatory Affairs.The OpportunityAs a regulatory affairs associate, you will play a critical role in enabling the registration of life-changing healthcare solutions for patients. Your focus will be on leading submissions and activities that maintain compliance within regulatory strategic partnerships, and mitigating risks.Key ResponsibilitiesDevelop...

  • Regulatory Affairs Expert

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Senior Specialist Regulatory AffairsThis is a highly skilled and experienced Senior Specialist Regulatory Affairs role in Sydney, Australia. The successful candidate will have significant expertise in regulatory affairs within the medical devices industry, with a proven track record of leading global regulatory submissions.Key Responsibilities:Author and...

  • Regulatory Affairs Professional

    7 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time

    Regulatory Affairs Role OverviewThis 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 Affairs Specialist

    1 day 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...