Regulatory Affairs and Quality Assurance Associate, Singapore

at  Device Technologies Australia

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…

We are seeking a highly motivated and detail-oriented Regulatory Affairs and Quality Assurance Associate to join our team in Singapore. The successful candidate will play a key role in ensuring compliance with regulatory requirements and maintaining high-quality standards for our medical devices.

ABOUT YOU…

At Device Technologies, we succeed through our commitment to four key values:
Delivering Innovation – We encourage and reward fresh ideas and are committed to supporting our people to make change.
Seeking Collaboration – We support each other in our combined mission to help others achieve their goals.
Taking Ownership – We believe in equipping our people to take responsibility and accountability in their roles and trust them to get the job done.
Practising Good Business – Our success is built on a mix of intuition and experience and we foster an environment where all voices are heard and nobody is afraid to make mistakes.
Our ideal candidate for this role aligns with these values.

EXPERIENCE REQUIRED:

• 2 years of experience in both Regulatory Affairs in Singapore and familiar with quality management system;
• 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.

• 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 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 relevant country;
• 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 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;
• Maintain the good distribution practice for Medical Device QMS in Singapore;
• Assist with all mandatory reporting requirements for recalls, adverse incidents and other issues, as directed;
• Display the core values and behavioural 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.