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…
Join Device Technologies as a Regulatory Affairs and Quality Assurance Associate!
We're seeking a detail-oriented professional with a strong background in compliance and product registrations. In this dynamic role, you'll help ensure our medical technologies meet the highest regulatory and quality standards. If you're ready to make a meaningful impact in healthcare, apply now and become part of a team dedicated to advancing patient outcomes.
Key Responsibilities:
Regulatory Affairs
- Collaborate with RAQA Management and Business Management to ensure effective and timely regulatory applications in the target region.
- Assess requirements for allocated product or product range to ensure complete regulatory compliance in the target region.
- Liaise with both local and overseas suppliers/manufacturers on regulatory issues and to obtain required documentation for regulatory compliance and new applications.
- Prepare and lodge regulatory applications in relevant regions.
- Develop and maintain excellent working relationships with relevant regulatory bodies including various government departments.
- 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.
- Investigate and resolve quarantined non-conforming product according to internal quality procedures.
- Review and process internal new product requests and marketing materials according to internal quality procedures.
- Assist with all mandatory reporting requirements for recalls, adverse incidents, and other issues, as directed.
- Assist with QMS responsibilities in region including process documentation, auditing of internal processes, training, participation in external audits
Product Complaints & Post Market
- Administer the Product Complaint system, including maintaining accurate and up-to-date records of all complaints.
- Liaise with overseas suppliers, customers, sales team, and internal staff to obtain effective and timely outcomes.
- Investigate complaints, ensuring accuracy and completeness of information prior to recording.
- Notify complaints to relevant manufacturer and Regulatory Affairs, coordinate assessment of event reportability and notification to authorities as required.
- Ensure effective follow-up on completed complaints, including provision of replacement product and/or credit, follow-up letter to customer, etc.
- Regular reporting to RA management as required; collate product complaints information for annual reporting.
- Present Product Complaints process to new employees during company inductions.
- Understand and communicate Adverse Events (AE) and/or Field Safety Corrective Actions (FSCA) to country RAs in the region.
- Ensure AE and FSCA are executed in a timely manner and documents are in place and closed.
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.
Experience required:
- At least 2 years' experience with in the relevant local regulatory environment
- Strong attention to detail and familiarity with medical terminology
- Proficiency in Microsoft Word and Excel
- Excellent organizational and communication skills (written and verbal in English, and local language where required)
- Ability to work effectively under pressure
- Capable of working independently and collaboratively within a team
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.
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