Senior Regulatory Affairs Expert

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $138,000 - $188,500

Regulatory Affairs Specialist

Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to lead our global regulatory strategy and submission execution for physical products manufactured by our company. As a key member of the team, you will play a critical role in shaping the future of our business.

Main Responsibilities:

  • Develop and execute global regulatory submissions, including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
  • Analyze device-specific requirements and translate them into clear, well-supported regulatory documentation.
  • Collaborate with regional teams to ensure reusable, scalable submission approaches and consistent technical content.
  • Lead regulatory assessments of design and process changes.
  • Provide regulatory input on system-level verification, biocompatibility, human factors, and labeling updates.
  • Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.

Qualifications & Experience:

  • Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.
  • 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).
  • Proven experience leading or coordinating global regulatory submissions.
  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.

  • Regulatory Affairs Expert

    2 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

    2 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

    16 hours 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...

  • Regulatory Affairs Expert

    1 day 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...

  • Expert Regulatory Affairs Professional

    1 day ago

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

    Job Title: Regulatory Affairs ExpertJob 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...

  • Senior Regulatory Affairs Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeregulator Full time $90,000 - $120,000

    Job DescriptionWe are seeking a highly skilled professional to manage the operational and technical aspects of regulatory affairs for our marketing affiliate.The purpose of this role is to execute the regulatory plan to ensure the success of new product registration, line extensions and new indications in alignment with the business plan, while maintaining...

  • Regulatory Affairs Manager

    3 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...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Job DescriptionThe Regulatory Affairs team plays a crucial role in shaping regulatory strategy and submission execution for physical products. As a Senior Specialist, you will lead submission planning and execution, influencing design documentation and contributing to regulatory strategy.You will collaborate across functions to drive global submission...

  • Expert Regulatory Affairs Professional

    1 day 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...

  • Technical Regulatory Affairs Expert

    5 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Senior Specialist Regulatory Affairs Job DescriptionAbout the RoleThe Senior Specialist Regulatory Affairs will be responsible for leading regulatory strategy and execution for ResMed's core portfolio of devices. This includes authoring and reviewing global regulatory submissions, interpreting device-specific requirements, and aligning closely with Regional...