Aps6 Medical Device Ivd Reviewer

2 weeks ago

Sydney, New South Wales, Australia face2face Recruitment Full time

Closing Date:5pm Monday 6 February 2023**
face2face reference:579572

Location:
Canberra, Adelaide, Brisbane, Melbourne, Perth, Sydney

Hours:
full-time

Contract length:
Until June

Entry requirements:
Australian Citizen + National Police Check

Pay range:
$80 p/h ex super

About the role:


This branch is responsible for the post market activities of medical devices, including in vitro diagnostic medical devices (IVDs), and monitoring them throughout their lifecycle to ensure they continue to meet appropriate standards.


Duties

  • Undertaking assessment of the technical documentation and data, collating expert advice relevant to the assessment, preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations, and exercising delegation where appropriate.
  • Undertaking under limited direction, risk assessment and Investigation of signals associated with medical devices.
  • Providing detailed in vitro diagnostic, sequence alignment, and antigen/protein modelling expertise in the context of medical device technology, including anticipating problems and contributing to issues management.

Required experience/skills

  • Relevant higher education qualification in health or science related field of studies or biomedical engineering
  • Experience in sequence alignment and antigen/protein modelling in the the context of in vitro diagnostic and medical device technology

Desirable experience/skills

  • Providing timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge.
  • Managing record keeping in accordance with the regulatory requirements and whole of
- government policy and standards

  • Maintain knowledge of relevant legislative and reporting requirements, Australian and International standards, quality assurance procedures and best practice models.
  • Experience in programming with Python, Java, or similar.

Loretta Pabian



APS

  • Medical Device Sales

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Products on contract - work with hospital accounts Territory performing very well Strong culture of trust and integrityTHE COMPANY YOU WOULD BE JOINING This global medical device/technology company bases everything they do on genuine care for health and wellbeing. They are a trusted medical services and solutions partner, driving healthy outcomes for people...

  • HTA Assessors, Medical Device

    2 weeks ago

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

    Join the federal government and contribute to the overall improvement of medical services access.Improve Public Health access through the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule. Fast paced & dynamic area requiring liaison between different work groups. 12 months contracts + possible extension. Canberra or Sydney based. We have 4 x...

  • Medical Device Sales

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Global leader in healthcare Do you have a clinical background? Consumables role for device rep with theatre sales experience NOT case support, but dealing with surgeons & theatre NUM'sTHE COMPANY YOU WOULD BE JOINING As a worldwide leader in medical solutions, this company designs, develops and manufactures a large range of products that meet the...

  • Aps Level 6

    1 week ago

    Sydney, New South Wales, Australia Australian Government - Department of Health Full time

    APS Level 6- $91,092 to $102,76 Canberra ACT, Melbourne VIC, Brisbane QLD, Sydney NSWOpportunities are available to join dynamic and innovative teams that play key roles in the regulation and evaluation of internationally and domestically manufactured medical devices. As part of the Medical Device Branches, you will contribute to the vision of the Health...

  • Sales & Marketing Manager - Medical Devices

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Lead this business unit in medical devices to ensure continued success Are you a passionate leader in sales & marketing in medical devices? Exceptional culture where it's acknowledged that People are the Best AssetTHE COMPANY YOU WOULD BE JOINING Global medical device company who is passionate and determined to continue on their current growth trajectory as...

  • Supply Chain Coordinator

    2 weeks ago

    Sydney, New South Wales, Australia KE Select Full time

    Global manufacturer of home-based IVD rapid test kits Actively growing company with a focus on R&D and new product development Administrative role managing international supply chains and logisticsSupply Chain Coordinator - In Vitro Diagnostics/Medical DevicesAbout the CompanyThis is your opportunity to join an innovative manufacturer of IVD products and...

  • 47-2024 - Aps5-aps6 Investment Review Officers and

    1 week ago

    Sydney, New South Wales, Australia Department of the Treasury Australia Full time

    APS5-APS6 Investment Review Officers and EL1 Assistant Directors, Foreign Investment Division APS5-APS6 Investment Review Officers and EL1 Assistant Directors, Foreign Investment DivisionJob number:47-2024Work type:Full-time and Part-timeLocation:ACT, NSW, Canberra, SydneyCategories:APS Level 5, APS Level 6, Executive Level 1Treasury's Investment Review...

  • APS 6, Medical Device Reforms Project Officer

    2 weeks ago

    Sydney, New South Wales, Australia Australian Government Department of Health Full time

    APS 6, Medical Device Reforms Project Officer (non-ongoing)The Devices Post Market Reviews Section (DPMRS) of the Medical Devices Surveillance Brach (MDSB), is seeking and a non-ongoing APS Level 6 Reforms Project Officer for 12 months.DPMRS is responsible for complex monitoring, analysis, and review activities for post market regulatory programs for medical...

  • Medical Device Sales

    2 weeks ago

    Sydney, New South Wales, Australia TRESP Recruitment Full time

    Join an elite sales team & be supported in your career development Support EP & cardiac customers Cryoablation & Electrophysiology Excellent training and development opportunities availableTHE COMPANY: Our client is a globally recognised leader in medical devices with a strong focus on clinical excellence, science and innovation, a company that is passionate...

  • Entry Into Medical Devices

    2 weeks ago

    Sydney, New South Wales, Australia TRESP Recruitment Full time

    The TRESP tribe will kick-start your career in the rewarding Medtech industry Be supported by a dedicated team of experts in your transition to Medtech Building pathways for aspiring professionals to land that 'dream job' in MedtechTransitioning your career can be challenging to navigate. There is uncertainty and ambiguity to deal with... So why would you do...

  • Medical Sales

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Med device, hospital pharma sales reps or rookie theatre nurses considered Are you in hospital pharma sales and want to break into devices? Collaborative team, amazing culture Oncology therapiesTHE COMPANY YOU WOULD BE JOINING Leading, global innovator of medical devices and technologies that improve patient lives. Their mission is to improve the quality of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Medella Life Full time

    Location- Sydney- Contact name: Ethan Keating Job ref: 827 Published:about 2 hours agoJob Title: Regulatory Affairs Specialist (12-month Contract)Location: Hybrid - Sydney, AustraliaKey Responsibilities:- Regulatory Compliance: Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs....

  • HTA Assessors, Medical Device

    2 weeks ago

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

    Join the federal government and play a crucial role in enhancing medical services access.Enhance Public Health access through the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule.Dynamic environment that requires collaboration across different work groups.Offering 12-month contracts with potential extensions, based in Canberra or Sydney.Our...

  • Medical Sales

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Very strong reputation and credibility with customers Territory performing very well Pharmaceutical sales reps considered Strong culture of trust and integrityTHE COMPANY YOU WOULD BE JOINING This global medical device/technology company bases everything they do on genuine care for health and wellbeing. They are a trusted medical services and solutions...

  • HTA Assessors, Medical Device

    2 weeks ago

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

    Join the federal government and be part of the team that enhances access to medical services. Enhance Public Health access through the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule. Dynamically fast-paced area that involves liaising between various work groups. 12-month contracts with a potential for extension. Position based in Canberra or...

  • Medical Sales

    1 week ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Products on contract - work with corporate aged care accounts Territory performing very well Strong culture of trust and integrityTHE COMPANY YOU WOULD BE JOINING This global medical device/technology company bases everything they do on genuine care for health and wellbeing. They are a trusted medical services and solutions partner, driving healthy outcomes...

  • Medical Sales

    2 weeks ago

    Sydney, New South Wales, Australia Pettit Pharma & Device Search Full time

    Very strong reputation and credibility with customers Territory performing very well Pharmaceutical sales reps considered Strong culture of trust and integrityTHE COMPANY YOU WOULD BE JOINING This global medical device/technology company bases everything they do on genuine care for health and wellbeing. They are a trusted medical services and solutions...

  • Supply Chain Coordinator

    2 weeks ago

    Sydney, New South Wales, Australia KE Select Full time

    Global manufacturer of home-based IVD test kits Actively growing company with a focus on R&D and new product development Administrative role managing international supply chains and logisticsSupply Chain Administrator - In Vitro Diagnostics/Medical DevicesAbout the CompanyThis is your opportunity to join an innovative manufacturer of IVD products and medical...

  • Medical Device Kit Assembler

    1 week ago

    Sydney, New South Wales, Australia Tresp Recruitment Full time

    Gain hands-on experience with orthopaedic implants. Opportunities for professional and leadership development. Be part of a motivated and energetic team. The Company:This company offers one of the most diverse orthopaedic portfolios in the world. It includes joint reconstruction, trauma, spinal surgery, sports medicine and robotic assisted solutions.They...

  • Territory Manager Medical Devices Northern

    2 weeks ago

    Sydney, New South Wales, Australia KE Select Full time

    Territory Manager | Medical Devices | Northern Sydney/NNSWThe CompanyFor more than 30 years, this leading distributor of medical, pharmaceutical, and scientific products has been forming partnerships with global manufacturers which have allowed them to successfully provide a vast technical product offering across ANZ.With a portfolio of highly respected...