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Regulatory Affairs and Quality Assurance Associate
2 weeks ago
DTG Medical MY
Administration & Regulatory Affairs
Kuala Lumpur - Permanent - Full time
Job ID# 493641
Posted 30 Sep 2025
Closing
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, and become part of a team dedicated to advancing patient outcomes.
**Key Responsibilities**:
Regulatory Affairs
Assess requirements for allocated product or product range to ensure complete regulatory compliance in the target region.
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.
**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 communicati
