Gemma Staddon

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Gemma Staddon

Divisional Manager - Life Sciences

Placing Life Sciences talent across Medical Affairs, Regulatory Affairs, Quality Assurance, Health Economics & Market Access and Clinical Research for pharmaceutical and MedTech organisations in Australia and New Zealand.

Executive
Medical Affairs
Regulatory Affairs
Quality Assurance
Health Economics & Market Access
Clinical Research

Gemma works within the Life Sciences division at HPG, partnering with pharmaceutical and Medical Device organisations to place specialist talent across Medical Affairs, Regulatory Affairs, Health Economics & Market Access, Quality Assurance and Clinical Research. Her coverage spans from associate level through to Medical Director, Market Access Director and Regulatory Affairs Director appointments, across Australia and New Zealand.

A thorough, candidate-focused approach defines how Gemma works. Clients rely on her for a clear understanding of the functional depth each role demands, whether that is the scientific rigour required in Medical Affairs, the compliance frameworks underpinning Regulatory and Quality, or the commercial acuity needed in Market Access. Candidates value her for the same attention to detail, and for matching them to roles where their expertise will have genuine impact.

Gemma brings more than ten years of experience across sales and account management, with seven of those spent working within Australia's healthcare industry. That grounding in the commercial side of the sector gives her an informed perspective when engaging with both clients and candidates across the Life Sciences functions she covers.

For Life Sciences appointments across Australia and New Zealand, Gemma is the right conversation to have.

Specialising in

Jobs by Gemma Staddon.

Engineering,IT

Software Test Engineer

Brisbane
Competitive salary package

Benefits Join a global medical technology company developing innovative solutions to improve patient outcomes Work across software and system verification and validation within medical devices Opportunity to work within a fast-paced agile product development environment About the company This global medical technology organisation is focused on advancing patient care through innovative technologies and high-quality medical device solutions. About the opportunity An exciting opportunity is available for a V&V Engineer to join an established team based in Brisbane. Working across software and system development projects, you will be responsible for supporting verification and validation activities throughout the product development lifecycle. You will work closely with cross-functional engineering, quality and regulatory teams to ensure software requirements, system designs and user needs are effectively verified and validated. This is an excellent opportunity for an engineer with 2–3+ years of experience who enjoys hands-on testing, technical problem solving and working within a regulated product development environment. Duties Develop, execute and maintain software and system V&V test plans, protocols and reports Review product requirements, software specifications and design documentation to develop comprehensive test cases Perform hands-on software verification and validation testing across new products and product enhancements Document test results, identify defects and work with development teams to investigate and troubleshoot software issues Track testing progress, defects, risks and issues throughout the development lifecycle Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory Affairs and Product Development teams Support test planning, test automation initiatives and continuous improvement activities Review software documentation and contribute to quality and compliance activities Support regulatory submissions through the preparation and provision of V&V documentation Skills and Experience Tertiary qualification in Biomedical Engineering, Software Engineering, Computer Engineering, Electrical Engineering, Computer Science or a related discipline 2–3+ years of experience in software verification and validation, software quality assurance or medical device development Experience working within a regulated industry, ideally medical devices Understanding of software development lifecycle and software V&V methodologies Experience developing test plans, protocols, test cases and verification reports Strong technical writing and documentation skills Strong analytical and problem-solving capability Experience working with cross-functional technical teams Culture Join a collaborative and quality-focused environment where engineering, quality, regulatory and product teams work closely together. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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Regulatory Affairs,Life Sciences

Regulatory Affairs Manager

Sydney
Competitive salary package

Benefits • ANZ leadership role with genuine strategic influence • Lead and develop an established Regulatory Affairs team • Broad exposure across new registrations, lifecycle management and portfolio growth • Join a growing healthcare business with an expanding portfolio and pipeline About the company This established healthcare organisation operates across Australia and New Zealand, partnering with a broad range of products and businesses across the pharmaceutical sector. With continued growth across the region, the business offers a fast-moving and commercially focused environment where Regulatory Affairs plays an important role in portfolio strategy, new opportunities and successful product launches. About the opportunity An exciting opportunity has become available for an experienced Regulatory Affairs leader to take responsibility for the ANZ regulatory function. Leading a small team, you will oversee regulatory strategy and execution across Australia and New Zealand while remaining close to key submissions, new registrations and complex regulatory projects. This is broader than a traditional Regulatory Affairs management position. You will work closely with senior leadership, commercial teams and external partners to assess new opportunities, shape regulatory strategy and provide guidance around pathways, timelines, risk and feasibility. The role would suit someone who enjoys leading people but still wants to remain connected to the technical and strategic side of Regulatory Affairs. Duties • Lead, coach and develop the Regulatory Affairs team • Set priorities and oversee regulatory workload across the portfolio • Develop regulatory strategies for new product registrations and lifecycle activities • Provide oversight of submissions to the TGA and Medsafe • Support new registrations, variations, transfers and post-approval activities • Lead complex or business-critical regulatory projects • Provide regulatory input into new product opportunities, portfolio expansion and business cases • Assess regulatory pathways, timelines, risks and resource requirements for prospective opportunities • Partner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business Development • Build strong relationships with external partners and provide strategic regulatory advice • Support regulatory aspects of product launches, manufacturing changes and artwork updates • Contribute to regulatory process improvement, compliance and inspection readiness • Monitor team resources, project requirements and regulatory service delivery • Contribute to broader ANZ leadership discussions and business planning Skills and Experience • Extensive pharmaceutical Regulatory Affairs experience across the Australian market • Strong knowledge of TGA regulatory requirements and ideally experience across New Zealand/Medsafe • Demonstrated experience managing new registrations as well as ongoing lifecycle activities • Previous people leadership experience, including coaching and developing regulatory professionals • Comfortable remaining hands-on and providing technical guidance when required • Strong understanding of regulatory strategy and the commercial implications of regulatory decisions • Strong stakeholder management skills with the confidence to work with senior internal and external stakeholders • Able to manage multiple priorities within a changing and commercially focused environment • Proactive, solutions-focused and comfortable taking ownership Culture Join a collaborative and agile environment where Regulatory Affairs has strong visibility across the wider business. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

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Quality Assurance

QA Engineer

Sydney
Competitive salary + benefits

Benefits • Permanent full-time opportunity within a global med-tech company • Work across innovative medical devices and SaMD • Exposure to global quality systems, regulatory requirements and cross-functional projects About the company Join a global medical technology organisation focused on developing innovative solutions that improve patient outcomes. With an established international presence, the business operates within highly regulated healthcare environments and continues to invest in technology, quality and product development. About the opportunity An exciting opportunity is available for a QA Engineer to join this growing team here in Sydney. Working as part of a global Quality Assurance function, you will support quality and compliance activities across medical devices, with a particular focus on SaMD. This is a varied position covering quality systems, complaint handling, CAPA, non-conformances, audits, risk management and design controls. You will work closely with Regulatory Affairs, Engineering, Operations, Sales and Marketing to ensure quality requirements are embedded throughout the product lifecycle. Duties • Support compliance with ISO 13485, ISO 14971 and internal Quality Management System requirements • Assist with internal, external and TGA audits and inspections • Support investigation and documentation of complaints, non-conformances and CAPAs • Assist with risk assessments and ongoing quality improvement activities • Maintain controlled documents and quality records within the QMS • Support quality and compliance training across the organisation • Assist with Design Controls activities supporting new product development projects • Partner with Engineering, Regulatory Affairs, Operations, Sales and Marketing teams • Participate in cross-functional projects to ensure quality and regulatory requirements are met • Support alignment between Australian quality activities and global policies and procedures Skills and Experience • Bachelor’s degree in Engineering, Science or a related discipline • 2 + years in Quality Assurance within the medical device industry • Working knowledge of ISO 13485 and medical device quality systems • Experience working with SaMD would be an advantage • Strong technical writing and controlled documentation experience • Exposure to design controls and product or software lifecycle processes • Strong analytical and problem-solving skills • Collaborative approach with the ability to work across multiple business functions Culture Join a collaborative and quality-focused environment where teams work closely across Quality, Regulatory, Engineering and Operations. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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Medical Affairs

Medical Information & PV Associate

Sydney
Competitive salary package

Benefits Broad role across Medical Information, Pharmacovigilance and Managed Access Programs Join a collaborative Medical Affairs team within the pharmaceutical industry Part-time opportunity – a role that will have genuine impact. About the company Join an established pharmaceutical organisation committed to improving patient access to medicines and delivering high-quality support to healthcare professionals and patients. About the opportunity Reporting to the Manager in Sydney, you’ll play a key role in supporting Medical Information, Pharmacovigilance and Managed Access Programs across the business. This is a hands-on role offering broad exposure across Medical Affairs, making it a great opportunity for someone early in their pharmaceutical or biotech career who is organised, detail-oriented and keen to build their experience across multiple areas. Duties Support day-to-day Medical Information, Pharmacovigilance and Managed Access Program activities Maintain approved Medical Information materials, including localisation, version control and lifecycle management Review routine Medical Information vendor reports and identify trends or opportunities for improvement Assist with escalated Medical Information enquiries and development of new materials Process approved patient orders and maintain Managed Access Program trackers and documentation Identify and escalate potential barriers affecting medicine supply or compliant patient access Maintain Pharmacovigilance documentation and activity tracking to support compliance and inspection readiness Support awareness and timely reporting of adverse events and other safety information Contribute to process improvements across Medical Information, Pharmacovigilance and Managed Access Programs Support cross-functional projects and broader priorities as required Skills and Experience Degree in Pharmacy, Nursing, Medical Science or another relevant health discipline Ideally at least 12 months' experience within the pharmaceutical or biotechnology industry Experience or exposure to Medical Information, Pharmacovigilance, Medical Affairs or Managed Access Programs is highly regarded Completion of Medicines Australia Code of Conduct Strong organisational skills with excellent attention to detail Ability to manage competing priorities and deliver accurate, high-quality work Strong written and verbal communication skills Reliable, proactive and able to learn quickly Culture Join a collaborative and supportive environment that values quality, compliance and continuous improvement. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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COMBINED EXPERIENCE

At HPG, we pride ourselves on bringing together a diverse group of professionals with extensive backgrounds in the healthcare recruitment industry. Our combined years of experience and specialised knowledge ensure that we deliver unparalleled service to our clients and candidates. By working collaboratively, we harness our collective expertise to meet and exceed your goals and expectations, providing tailored solutions and exceptional support every step of the way. Discover how our unified team effort drives success in every project we undertake.

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Gemma Staddon