Regulatory Affairs Specialist

6 days ago

Sydney, New South Wales, Australia ProductLife Group Full time
Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring compliance with all regulatory processes and procedures.

Key Responsibilities:
  • Manage regulatory activities for launch, including preparation and submission of technical/site transfer applications and marketing authorisation applications.
  • Ensure compliance with all regulatory processes, in readiness for both internal and external audits.
  • Provide regulatory support in relation to local requirements, including cessation of marketing/sunset clause/withdrawal of MAs.
  • Inform reliant markets of changes to reference product.
  • Prepare and submit technical/site transfer applications and marketing authorisation applications.
  • Assist with license applications as required.
  • Provide regulatory data for PV reporting.
  • Respond to internal requests for technical and/or regulatory information.
Requirements:
  • 5-8 years relevant experience in regulatory affairs.
  • Proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget.
  • Experience of medical devices would be beneficial.
  • Experience of other EU region would be beneficial.
  • Previous experience of people management/coordination would be an advantage.
  • Good IT skills/knowledge.
  • Good organizational skills.
  • Good communication skills.
  • Pro-active attitude and able to work on own initiative as well as part of a team.
  • Ability to prioritize different workloads/multi-task.
  • Personal responsibility for ensuring a high standard of work.
What We Offer:
  • Competitive salary range: $54,155.78 – $100,000.00 per year.
  • Full-time position with a 10 hour shift schedule.
  • Australia (Preferred) work authorisation.

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    5 days ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    {"h1": "Regulatory Affairs Specialist", "p": "At Device Technologies Australia Pty Ltd, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the quality, safety, and efficacy of our medical devices throughout their life cycle.Your key...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    27 minutes ago

    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. As a Regulatory Affairs Specialist, you'll play a critical role in ensuring our products meet the...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryThe Regulatory Affairs Specialist will lead regulatory affairs strategy to be aligned with objectives of our post market products. This role will be responsible for planning and coordinating regulatory post market strategies, representing Regulatory Affairs on selected post market cross-functional teams, and developing and implementing submissions...

  • Regulatory Affairs Specialist

    1 week ago

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

    About the RoleWe are seeking a highly skilled Regulatory Affairs Associate to join our Medical Devices Consulting team in Australia.In this role, you will have the opportunity to work on various medical devices technologies, supporting quality and regulatory activities.Your primary objective is to ensure licensing and regulatory compliance of client...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Pharmalex Full time

    Unlock Your Career PotentialWe are a dynamic company with a passion for innovation and growth. If you are looking for a challenging role that will help you develop your skills and expertise, we have an exciting opportunity for you.About the RoleWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our Medical Devices...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Director

    3 days ago

    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...

  • Regulatory Affairs Specialist

    2 days ago

    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...

  • Regulatory Affairs Specialist

    6 days ago

    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,...

  • Regulatory Affairs Specialist

    6 days ago

    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...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    7 days ago

    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...