Quality Assurance and Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia KE Select Full time

About the Company:

Our client is a prominent global manufacturer recognized for its innovative products utilized in the testing of various infectious diseases. As the organization continues to expand, they are seeking to recruit a Quality Assurance and Regulatory Affairs Associate to enhance their operations in Sydney. This role presents an exciting opportunity to engage with both quality and regulatory functions while gaining insights from a seasoned leader in QA/RA. The company is committed to fostering an inclusive environment where diversity is acknowledged and valued.

About the Role:

This position offers a distinctive chance to work within an In Vitro Diagnostic (IVD) manufacturer/sponsor, encompassing responsibilities across both quality and regulatory domains. The selected candidate will play a vital role in improving the quality management system and will also assist in the preparation of dossiers and technical documentation for submissions to IVDR, WHO, and TGA.

Key Responsibilities:

  • Gather and analyze data on Quality Management System (QMS) processes, contributing to the development of Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), Document Control, and Complaint Management.
  • Assist in technical writing and the formulation of Standard Operating Procedures (SOPs).
  • Support post-audit CAPA investigations in collaboration with the Research and Development team.
  • Contribute to regulatory file maintenance initiatives.
  • Investigate emerging regulatory and technical areas pertinent to departmental projects.
  • Create engaging PowerPoint training presentations on Management Quality System (MQS) and new regulations.
  • Establish and nurture relationships with key stakeholders across various functions.

This is an excellent opportunity for an individual to leverage their quality and regulatory expertise within the Diagnostics or Medical Device sector. The ideal candidate will possess a background in medical science, biochemistry, or biomedical engineering, along with 2-3 years of relevant QARA experience in a manufacturing context. Furthermore, the candidate should be an enthusiastic, collaborative team player eager to learn and grow.

About You:

  • Practical knowledge and comprehension of ISO 13485 standards.
  • Demonstrated technical writing capabilities.
  • Effective communication and interpersonal skills.
  • Strong attention to detail.
  • Experience with QMS and proficiency in Microsoft Office applications, including Word, PowerPoint, and Excel.
  • A team-oriented individual with a proactive attitude.

Flexibility in office attendance is available; however, a minimum of three days in the office is required.

How to Apply:

If this role aligns with your qualifications and interests, we encourage you to submit your application. Our team is currently short-listing candidates for this position.

KE Select is a leading Australian recruitment partner specializing in Scientific and Medical roles across the Life Sciences, Medical, Clinical, Hospital, and Healthcare sectors. We focus on both Permanent and Temporary recruitment throughout Australia and New Zealand. For candidates seeking new opportunities or companies in need of industry-specific recruitment services, we invite you to explore our website for further information.

  • Quality Assurance and Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia KE Select Full time

    About the Company:Our client is a prominent global manufacturer recognized for its innovative products utilized in the testing of various infectious diseases. As the organization expands, they are seeking to recruit a Quality Assurance and Regulatory Affairs Associate to enhance their team in Sydney. This position presents an exciting opportunity to engage...

  • Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Regulatory Affairs & Quality Assurance ManagerAre you a seasoned professional looking for a new challenge in the medical devices industry? We have an exciting opportunity for a Regulatory Affairs & Quality Assurance Manager to join our team at Hengandhurst.About the RoleWe are seeking a highly motivated and experienced individual to lead our regulatory...

  • Quality Assurance and Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia KE Select Full time

    About the Company:Our client is a leading global manufacturer recognized for its innovative products utilized in the diagnosis of various infectious diseases. As a result of their ongoing expansion, they are seeking to appoint a Quality Assurance and Regulatory Affairs Associate in Sydney. This role presents an exciting opportunity to engage with both...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Job Title: Regulatory Affairs & Quality Assurance ManagerCompany: HengandhurstJob Type: Full-timeLocation: SydneyAbout Us: Hengandhurst is a fast-growing medical device company with a diverse portfolio of products. We are seeking a highly motivated and experienced Regulatory Affairs & Quality Assurance Manager to join our team.Job Summary:Develop and...

  • Regulatory Affairs Specialist

    7 days ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Job DescriptionCompany OverviewHengandhurst is a leading medical device distribution company with a wide portfolio of products and a strong presence in the ANZ market.Job SummaryWe are seeking an experienced Regulatory Affairs & Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for developing and...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Job Title: Regulatory Affairs & Quality Assurance ManagerCompany: HengandhurstJob Type: Full-timeLocation: SydneyAbout Us: Hengandhurst is a fast-growing medical device company with a diverse portfolio of products. We are seeking a highly motivated and experienced Regulatory Affairs & Quality Assurance Manager to join our team.Job Summary:Develop and...

  • Regulatory Affairs Specialist

    7 days 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

    5 days 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 day 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

    5 days 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

    3 days 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 Michael Page Full time

    About Our CompanyMichael Page is a leading recruitment agency specializing in professional staffing solutions. With a strong presence in the pharmaceutical industry, we understand the importance of regulatory compliance and expertise.Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our pharmaceutical...

  • Regulatory Affairs Specialist

    16 hours 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 day 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

    16 hours 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 day 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

    5 days 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 Michael Page Full time

    About Our CompanyMichael Page is a leading recruitment agency specializing in professional staffing solutions. With a strong presence in the pharmaceutical industry, we understand the importance of regulatory compliance in ensuring the success of our clients.Job DescriptionKey Responsibilities:Regulatory Compliance:Monitor and interpret relevant regulations,...

  • Regulatory Affairs Specialist

    1 day ago

    Sydney, New South Wales, Australia Michael Page Full time

    About Our ClientMichael Page is a leading recruitment agency with a strong presence in the pharmaceutical industry. Our client is a reputable company that specializes in providing market-ready, TGA registered & listed, over-the-counter and prescription products, as well as vitamins, mineral supplements, medical devices, and various other niche products.Job...

  • Regulatory Affairs Associate

    5 days ago

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

    About UsDevice Technologies Australia Pty Ltd is a leading medical solutions provider dedicated to improving patients' lives through innovative technology and services. With over 30 years of experience, we have established a reputation for quality, dedicated service, and ongoing support.Our CultureWe foster a culture built on empowering our people to achieve...