Quality, Regulatory

**Empowering careers at ARJO**

**At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?**

**This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.**

**What is the Opportunity?**
We have a great opportunity for an experienced Quality Regulatory and Compliance Officer - SEA to join our growing organisation.

The primary focus of the role is to ensure that the Quality Assurance, Regulatory Affairs and Post Market are implemented, current and monitored within our South East Asia region.

This role works in collaboration with the local Sales and Service (SSU) teams to define and implement QA strategies, promote quality in service delivery, continuous improvement, monitoring compliance, identifying and evaluating deficiencies. Whilst minimising business risk when operating within the SS:620, ISO 9001 and 13485 Quality Management Systems as well as adhering to our local standard operating procedures.

This role is key to ensuring products supplied in South East Asia are registered, meet and are compliant with the requirements of regulatory bodies and local SEA law.

The role is based out of our Singapore office, and you will report to the the Senior Manager, Quality & Regulatory Compliance - RoW, who is based in Perth, Western Australia.

**Key Responsibilities**
- Ensure product registrations within South East Asia are processed and maintained in conjunction with our distributor market.
- Assist in the implementation, maintenance and certification of Quality Management policies and procedures to meet the requirements of ISO9001.
- Document and maintain customer complaints into the global complaints handling system (TrackWise)
- Ensure compliance with Good Distribution Practice for Medical Devices (GDPMDS) is achieved and maintained in South East Asia SSUs.
- Ensure Global Management system SOP and associated documents are embedded in local system, and distributed to relevant or affected management and staff.
- Ensure Management and staff are fully trained, and understand their role in the quality management systems.
- Compliance with all legislative requirements regarding health and safety
- Cyclical Quality training for all staff.
- Ensure training records for all staff effected by the quality system are kept and maintained.
- Efficiently manage non-conformances within the business.
- Compile and present monthly Management Review reports
- Creation and maintenance of internal audit schedules as well as participate in audits conduct by Group or Regional QRC dept.
- Conduct and/or ensure internal quality audits are conducted.
- Conduct supplier quality audits as required
- Ensure compliance in OHS regulations and be included in the OHS committee.

**Skills & Experience**
- Tertiary qualification, accredited course in Quality management or OHS desirable.
- 3 years’ experience in a Quality Assurance environment, preferably in the medical device industry.
- Sound knowledge of regulatory requirements within South East Asia
- Sound knowledge of relevant Singaporean and International standards particularly ISO9001.
- Proven record of QMS management and complaint handling.
- Exceptional customer service focus, with advanced communication and interpersonal skills
- Intermediate to Advanced level of Microsoft Excel
- Internal Auditors Qualification desirable

**What We Will Offer In Return**

Work in a highly engaged and vibrant workplace culture, which includes:

- A flexible work environment, including hybrid (remote and office) work arrangements,
- Employee Assistance Program
- Community volunteering opportunities
- Continuing education and career development plan

You will support our vision to be the most trusted partner in driving healthier outcomes for people facing mobility challenges. In return, we recognize and value our global employees. You will have our full support, training and opportunities for professional development

**Why diversity matters to us**

At Arjo, we believe in the power of diversity. We strongly encourage applicants from all parts of society, which means building a more diverse, equitable, inclusive and engaging environment - not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.

Successful applicants will be required to undergo relevant reference checks and a pre-employment medical check prior to appointment.

For those with a passion to improve mobility outcomes for others, a rewarding career at Arjo awaits.

We look forward to receiving your resume and cover letter

**About Arjo**

**At Arjo, we believe that empowering movement within healthcare environm