About us…

Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading edge technology and services, supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world. Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support provided by our people. With HQ in Sydney, the company continues to grow, representing over 200 trusted brands, and employing over 1000 highly skilled staff located across Australia, New Zealand and Asia.

Geared towards optimal performance, our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

The opportunity…

The Regulatory Affairs and Quality Assurance Associate will be responsible for regulatory functions and ensuring ongoing compliance for both new and existing products within the Device Technologies portfolio, while also assisting in the establishment of the organization’s quality management system.

Key Responsibilities:

• Collaborate with RAQA Management and Business Management to ensure effective and timely regulatory applications in Thailand
• Assess requirements for allocated product or product range to ensure complete regulatory compliance in Thailand
• Liaise with both internal team and suppliers/manufacturers on regulatory issues and to obtain required documentation for regulatory compliance and new applications
• Prepare and lodge regulatory applications in Thailand
• Maintain all regulatory technical files, databases, spreadsheets and internal registers for allocated product ranges
• Ensure accuracy and currency of data held on all databases (SAP, the Hub, etc.) for allocated product ranges
• Collaborate with Business Management and Sales teams to provide relevant   regulatory information as required for tenders, quotations, customer requirements, product launches and principal meetings etc
• Investigate and resolve quarantined non-conforming product according to internal quality procedures
• Review and process internal new product requests according to internal quality procedures
• Review marketing materials according to internal quality procedures
• Assist with all mandatory reporting requirements for recalls, adverse incidents   and other issues, as directed
• Display the core values and behavioral code of Device Technologies
• Assist RAQA Management with other functions as required
• Provide RA department with back up when other team members are on leave, or as otherwise required.

About you...

At Device Technologies, we succeed through our commitment to five key values:

Delivering Innovation - We constantly seek new ideas, technologies, and approaches to meet evolving customer needs and market demands. Through our innovation we continually adapt and transform for our people, our customers and our future success.

Seeking Collaboration - By embracing collaboration we tap into diverse perspectives, skills, and resources to drive innovation, solve complex problems, and achieve common goals. 

Taking Ownership - We embrace accountability and initiative. It fosters trust, collaboration, and empowers our people to drive success through proactive responsibility.  

Practising Good Business - We strive to embody integrity, responsibility, and sustainability.  It involves ethical conduct, transparency, and a commitment to social and environmental stewardship. 

Championing the Customer - By placing customers at the heart of decision-making and operations, we enhance experiences, foster loyalty, and collectively strive to improve patient outcomes.

Our ideal candidate for this role aligns with these values.

Essential

• Understanding of Device Technologies policies and procedures including any vaccination and background checks in line with your role and responsibilities.
• Knowledge of, and experience in, the relevant local regulatory environment.
• Knowledge and experience with quality management system
• Excellent attention to detail;
• Good understanding of medical terminology;
• Excellent computer skills (Word, Excel);
• Excellent organisational skills;
• Excellent communication skills, both written and oral in English and local language;
• Ability to work well under pressure;
• Ability to work well independently and as part of a team.
• Meets the educational background requirements pursuant to MOHR No. 14/2021.

Desirable

• Experience using SharePoint, SAP and Adobe Professional.

Interested?

To apply for this opportunity, please click on the 'apply' button to be redirected to our candidate application portal.   

At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business.

Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.

Please note: Device Technologies will undertake pre-employment checks via our accredited background check provider for the successful candidate to ensure that Device Technologies is meeting legislative obligations and the information a candidate provides is accurate. For all roles, an offer of employment will be subject to the following pre-employment checks: identity check, reference checks, right to work in location (checks for visa holders), police integrity. By proceeding and applying for the role, you acknowledge our hiring process and agree to undertake the required pre-employment checks if successful.

It is also a mandatory requirement for certain roles within our organisation, where the successful applicant may be required to present certifications and/or vaccinations status as per role requirements.  Evidence of certificates or vaccination status will be requested during the interview process by management to qualify fit for role and prior to any offer.