Verified Job
Jobs
Quality, Regulatory and Sustainability Manager
Jobs
#682124
Full Time
Job Description
Full job description
Invacare is a proud supplier of mobility and medical equipment that is used in hospitals, aged care facilities and homes all around the world. We have an extensive line of products which includes manual and powered wheelchairs, mobility scooters, beds and mattresses, patient lifters, ramps and more.
Invacare Europe & Asia Pacific and Direct Healthcare Group have recently merged creating DHCare, a global medical device company that supports efforts to move health forward by delivering innovative and leading solutions for individuals whose lives are impacted by reduced mobility.
About the role
We are seeking and experienced Quality, Regulatory and Sustainability Manager to join our team, leading quality, regulatory and ESG functions across our ANZ business. This is an autonomous role and is the primary contact for ANZ, working very closely with our global Quality and Regulatory (QARA) teams in EMEA and the APAC Regional Leadership Team.
The Quality, Regulatory and Sustainability Manager is responsible for localising and embedding global quality systems, ensuring compliance with ISO: 13485, ISO:14001, TGA and Medsafe requirements, overseeing regulatory compliance and submission, leading ANZ audits, and championing continuous improvement and sustainability initiatives and strategies aligned with our global QARA and ESG objectives.
Other key responsibilities include:
Own and continuously improve the ANZ ISO13485 QMS and related quality systems
Lead internal and external audits including local ANZ cross audits and ensure ongoing regulatory compliance
Manage complaints, CAPA, non-conformances, supplier quality and product risk
Act as the primary liaison with TGA, Medsafe and external compliance bodies ensuring compliance with requirements for medical devices, including listing/notification processes, post-market surveillance obligations, field safety notifications, incident reporting, and recalls.
Oversee SOPs, document control and training
• Lead ISO 14001 compliance and deliver the EcoVadis sustainability assessment • Drive sustainability initiatives and report on ESG performance
Partner with commercial, people, operational and global teams to build capability and embed quality and compliance
About you
You are a confident and credible quality leader who can work with a wide range of stakeholders, balancing global standards with local realities. You bring a pragmatic, flexible and result oriented approach that focuses on driving continuous improvement while building strong and trusting relationships in the organisation.
We are looking for someone who brings:
A tertiary qualification in Quality, Science, Engineering or similar
5+ years’ experience in quality and regulatory roles within medical devices or regulated industries
Strong knowledge of ISO 13485, ISO 14001, GDP and ANZ regulatory frameworks
Audit leadership experience and exposure to sustainability or ESG initiatives
Excellent communication, judgement, critical thinking and problem-solving skills
Experience with TGA, Medsafe and global QMS/WMS environments will be highly regarded.
Why join us?
Invacare is an amazing values-based global organisation that makes a real difference in people’s lives and you’ll get to be part of us! We have a passionate and fun culture that’s committed to diversity and inclusion, ongoing professional development through on the job learning, secondments and training and the opportunity to work in cross-functional teams across the ANZ region. We have additional benefits, various flexible working options to support a healthy work/life balance and you'll work in a continuous improvement environment where your ideas will be heard and realised. If you’re passionate about helping others and are ready to join a company that truly puts others at the forefront of what we do, we would love to hear from you so please apply today.
Invacare is a proud supplier of mobility and medical equipment that is used in hospitals, aged care facilities and homes all around the world. We have an extensive line of products which includes manual and powered wheelchairs, mobility scooters, beds and mattresses, patient lifters, ramps and more.
Invacare Europe & Asia Pacific and Direct Healthcare Group have recently merged creating DHCare, a global medical device company that supports efforts to move health forward by delivering innovative and leading solutions for individuals whose lives are impacted by reduced mobility.
About the role
We are seeking and experienced Quality, Regulatory and Sustainability Manager to join our team, leading quality, regulatory and ESG functions across our ANZ business. This is an autonomous role and is the primary contact for ANZ, working very closely with our global Quality and Regulatory (QARA) teams in EMEA and the APAC Regional Leadership Team.
The Quality, Regulatory and Sustainability Manager is responsible for localising and embedding global quality systems, ensuring compliance with ISO: 13485, ISO:14001, TGA and Medsafe requirements, overseeing regulatory compliance and submission, leading ANZ audits, and championing continuous improvement and sustainability initiatives and strategies aligned with our global QARA and ESG objectives.
Other key responsibilities include:
Own and continuously improve the ANZ ISO13485 QMS and related quality systems
Lead internal and external audits including local ANZ cross audits and ensure ongoing regulatory compliance
Manage complaints, CAPA, non-conformances, supplier quality and product risk
Act as the primary liaison with TGA, Medsafe and external compliance bodies ensuring compliance with requirements for medical devices, including listing/notification processes, post-market surveillance obligations, field safety notifications, incident reporting, and recalls.
Oversee SOPs, document control and training
• Lead ISO 14001 compliance and deliver the EcoVadis sustainability assessment • Drive sustainability initiatives and report on ESG performance
Partner with commercial, people, operational and global teams to build capability and embed quality and compliance
About you
You are a confident and credible quality leader who can work with a wide range of stakeholders, balancing global standards with local realities. You bring a pragmatic, flexible and result oriented approach that focuses on driving continuous improvement while building strong and trusting relationships in the organisation.
We are looking for someone who brings:
A tertiary qualification in Quality, Science, Engineering or similar
5+ years’ experience in quality and regulatory roles within medical devices or regulated industries
Strong knowledge of ISO 13485, ISO 14001, GDP and ANZ regulatory frameworks
Audit leadership experience and exposure to sustainability or ESG initiatives
Excellent communication, judgement, critical thinking and problem-solving skills
Experience with TGA, Medsafe and global QMS/WMS environments will be highly regarded.
Why join us?
Invacare is an amazing values-based global organisation that makes a real difference in people’s lives and you’ll get to be part of us! We have a passionate and fun culture that’s committed to diversity and inclusion, ongoing professional development through on the job learning, secondments and training and the opportunity to work in cross-functional teams across the ANZ region. We have additional benefits, various flexible working options to support a healthy work/life balance and you'll work in a continuous improvement environment where your ideas will be heard and realised. If you’re passionate about helping others and are ready to join a company that truly puts others at the forefront of what we do, we would love to hear from you so please apply today.
