Current jobs related to Medical Device Compliance Specialist - Sydney, New South Wales - beBeeRegulatoryAffairs

  • Medical Device Compliance Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000

    Job Opportunity: Regulatory Affairs AssociateWe are seeking a highly skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for managing end-to-end regulatory submissions, leading regulatory strategy, and compiling technical files.Manage end-to-end regulatory submissions, including interactions with regulatory...

  • Senior Medical Device Compliance Officer

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $150,000 - $250,000

    Job OpportunityWe are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Main Responsibilities:Prepare and facilitate international regulatory submissions, including those for Australia, the US, and other...

  • Medical Device Specialist

    3 hours ago

    Sydney, New South Wales, Australia beBeeSterilization Full time $65,000 - $75,000

    Medical Device SpecialistThe primary goal of this role is to provide sterile medical equipment for use in patient care. This involves ensuring that all reusable medical devices are thermally disinfected and meet the required standards.Completion of a Certificate in Sterilisation Technology at a recognised educational institution.Previous experience working...

  • Medical Device Technical Support Specialist

    4 hours ago

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

    Technical Specialist for Medical Device SupportJob Description:A skilled technical professional is required to provide critical support for medical technology trials in Australia. The ideal candidate will have a strong understanding of human anatomy, experience working in operating theatres, and expertise in biomedical engineering.Key...

  • Medical Device Designer

    2 weeks ago

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

    Medical Device Design Specialist Role  In this position, you will collaborate with surgeons to plan and design implants and surgical procedures. Your key responsibilities will include digital planning, product development, CAD modeling, requirements gathering, and working closely with surgeons in the design of medical devices.Key Responsibilities:

  • Medical Device Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeEndoscope Full time $60 - $70

    Job SummaryThis is an exciting opportunity to work as a medical device specialist, responsible for the thorough cleaning and maintenance of endoscopy equipment. Your expertise will directly contribute to the comfort and well-being of our patients.About the RoleIn this position, you will be part of a dynamic team ensuring high standards of patient safety and...

  • Medical Device Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeField Full time $120,000 - $170,000

    We are seeking a highly skilled professional to join our team as a Technical Service Engineer.Job DescriptionThe successful candidate will be responsible for providing technical support and service delivery for medical devices and systems. This role involves working closely with cross-functional teams to address customer needs and exceed service...

  • Medical Device Regulatory Affairs Expert

    5 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000

    Job Title: Regulatory Affairs SpecialistAbout the Role:This is a unique opportunity for an experienced regulatory professional to contribute to our mission by ensuring continued product compliance across global markets.Main Responsibilities:Represent Regulatory Affairs on cross-functional teams to support post-market compliance effortsDevelop and implement...

  • Medical Devices Regulatory Specialist

    6 hours ago

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

    Regulatory Affairs Specialist OverviewThis role leads regulatory strategy and submission execution for all physical products where the legal manufacturer is involved—including masks, CPAP platforms, life-support ventilators, and accessories.Key Responsibilities:Autorize and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and...

  • Medical Device Technical Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeEngineering Full time $75,000 - $85,000

    Technical Services ProfessionalWe are seeking a skilled technical professional to join our team. The ideal candidate will be responsible for ensuring the effective execution of all technical service-related functions.Key Responsibilities:Conduct and/or coordinate the repair, maintenance of complex medical devices to ensure operational efficiency and...

Medical Device Compliance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $100,000 - $130,000
Regulatory Affairs Specialist

We are seeking an experienced and driven Regulatory Affairs (RA) specialist to play a pivotal role in guiding our regulatory strategy and managing product registrations. The successful candidate will ensure that products meet the required legal and safety standards for market access.

Key Responsibilities:
  • Define and execute people-centered change strategies, making an impact by driving adoption of new ways of working.
  • Collaborate effectively within the initiative team as well as with initiative stakeholders to identify needs, set, and execute the regulatory strategy.
  • Lead the preparation, review, and submission of regulatory applications for medical devices to relevant authorities, ensuring compliance with regulations.
  • Maintain up-to-date knowledge of local regulatory guidelines and industry standards.
  • Ensure product compliance with these standards throughout the product lifecycle.
Requirements:
  • Bachelor's degree in a relevant scientific or engineering field.
  • At least 3 years of regulatory affairs experience within the medical device industry.
  • In-depth knowledge of Australian regulatory requirements, including TGA guidelines, European Medical Device Regulation (EUMDR), and ISO 13485.
  • Strong understanding of global regulatory frameworks.
  • Excellent communication, organizational, and problem-solving skills.
About Us:

We are a health technology company committed to improving the lives of people everywhere through innovation and quality healthcare.