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


  • Sydney, New South Wales, Australia ResMed Inc Full time

    {"title": "Regulatory Affairs Specialist", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. in Sydney, Australia. As a key member of our Regulatory Affairs - Systems and Business Excellence Team, you will play a critical role in ensuring the compliance of our medical devices with global...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. as a Regulatory Affairs - Systems and Business Excellence Team member. The successful candidate will be responsible for ensuring the continuance of regulatory compliance of existing ResMed products, reviewing new and changing policies, regulations, and...


  • Sydney, New South Wales, Australia ResMed Full time

    Regulatory Affairs Student EngineerThe Regulatory Affairs function at ResMed plays a critical role in ensuring our products meet regulatory requirements. As a Student Regulatory Affairs Engineer, you will work closely with the Regulatory Affairs - Systems and Business Excellence Team to provide support and guidance on regulatory matters.Key...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job DescriptionJob Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. The successful candidate will be responsible for ensuring the regulatory compliance of our medical devices and providing support to our internal stakeholders and external regulators.Key...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Regulatory Affairs SpecialistResMed Inc is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Product Regulatory Affairs function, you will be responsible for leading regulatory affairs strategy to ensure compliance with regulatory frameworks and quality systems.Key Responsibilities:Develop and implement...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    {"h1": "Regulatory Affairs Coordinator", "p": "At ResMed Inc, we are seeking a highly skilled Regulatory Affairs Coordinator to support our regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This role involves assisting in the preparation of regulatory documents, maintaining records, and...


  • Sydney, New South Wales, Australia AMADA Senior Care Mesa Full time

    {"title": "Medical Devices Regulatory Affairs Associate", "subtitle": "Join Our Team", "content": "We are seeking a highly skilled Medical Devices Regulatory Affairs Associate to join our team in Australia. As a key member of our Medical Devices Consulting team, you will play a critical role in ensuring the regulatory compliance of our clients' products.Your...


  • Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleIn this role, you will be responsible for ensuring the regulatory compliance of client products, advising on licensing and marketing strategies, and managing regulatory submissions and approvals.You will...


  • Sydney, New South Wales, Australia ENG Con Full time

    {"title": "Regulatory Affairs Director", "content": "Job SummaryWe are seeking an experienced Regulatory Affairs Director to join our team at ENG Con. As a key member of our Pharmaceutical Regulatory Consulting team, you will be responsible for ensuring the regulatory compliance of client products and maximizing their commercial success.Key...


  • Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time

    Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our dynamic team at a global Animal Health Pharmaceutical company. This exciting role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.Key Responsibilities:Regulatory Affairs:Oversee and...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the development and submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a product...


  • Sydney, New South Wales, Australia On Q Recruitment Full time

    {"Job SummaryAs a key member of our Regulatory Affairs team at On Q Recruitment, you will play a pivotal role in supporting the compliance of healthcare products with legal and industry standards.Key Responsibilities:Develop and implement regulatory strategies for diverse product portfolios, ensuring alignment with business strategies and priorities.Prepare,...


  • Sydney, New South Wales, Australia On Q Recruitment Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs professional to join our team at On Q Recruitment. As a key member of our Regulatory Affairs team, you will play a pivotal role in supporting the compliance of healthcare products with legal and industry standards.Key ResponsibilitiesDevelop and implement regulatory strategies for diverse...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the development and submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a portfolio of...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. As a key member of our Global Product Regulatory Affairs function, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory postmarket strategies to...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. as a Specialist, Regulatory Postmarket Compliance. This role will be responsible for leading regulatory affairs strategy to ensure compliance with postmarket regulations and quality standards.Key ResponsibilitiesDevelop and implement regulatory postmarket...


  • Sydney, New South Wales, Australia Zimmer Biomet Full time

    Unlock Your Potential in Regulatory AffairsAt Zimmer Biomet, we're committed to pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader, we're dedicated to enhancing patient mobility and quality of life.Be Part of Our RAQA TeamAs an intern in our Regulatory Affairs and Quality Assurance (RAQA) team, you'll...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to support our regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices.Key ResponsibilitiesRegulatory Submissions: Assist in the preparation of regulatory documentation for product registrations, amendments, and renewals in...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the development and submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a product...


  • Sydney, New South Wales, Australia ResMed Inc Full time

    Job Summary:The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices.Key Responsibilities:Regulatory Submissions: Assist in the preparation of regulatory documentation for product registrations, amendments, and renewals in compliance with global...

Regulatory Affairs

3 months ago


Sydney, New South Wales, Australia Hengandhurst Full time
Regulatory Affairs & Quality Assurance Manager | Medical Devices | Sydney based
  • Sydney
  • Medical Device / Medical
Thrilling times for this fast-growing ANZ medical devices company with a wide, diversified and exiting portfolio. Highly collaborative and warm team.
  • Diverse and growing portfolio across the ANZ market.
  • Opportunity to join an expanding collaborative team.
  • Great opportunity for a fast-growing long-term career.

Become part of a thriving, independent ANZ medical device company dedicated to expanding its portfolio and product offerings. Renowned for its robust culture, seasoned professionals, and top-tier products, this company has achieved growth not only through business triumphs but also by strategically acquiring new products for distribution. As they continue to expand, they seek an ambitious and motivated Regulatory Affairs & Quality Assurance Manager.

Reporting directly to the Director of Business Development and Operations your key responsibilities will include:

  • Develop regulatory strategies for device approval, prepare and submit applications and ensuring compliance.
  • Management and update of QMS.
  • Maintain ISO 9001 standards and conduct audits to ensure compliance.
  • Post-Market Surveillance: handle complaints, adverse events, and recalls and potentially implement corrective actions with cross-functional teams.
  • Stay updated on regulations and trends and communicate changes for timely compliance.

To be considered for this role, you will have:

  • Bachelor's degree in a relevant scientific or engineering discipline; advanced degree is a plus.
  • Multiple years of experience in regulatory affairs and quality management within the medical devices industry.
  • Ability to work to deadlines and to prioritise accordingly with a strong attention to detail and project management capability.
  • Driven mindset, hands-on approach and supportive personality.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively across departments.

This presents a fantastic opportunity to join a top-tier medical device distribution company. Given its current business scenario, there is ample room for your growth and development. While you may not be an expert in all medical devices or quality systems, what matters most is your willingness to contribute to their exciting internal growth and readiness to face challenges. If you excel in an autonomous setting and value being part of a close-knit team, this role could be ideal for you. To apply, please click 'apply' and send your CV in word format. For further information, contactJasmineGarbino on

#J-18808-Ljbffr