We are a large Australian privately owned company that markets and sells high-quality capital equipment and medical device consumables.
Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading-edge technology and services, supplying hospitals and healthcare professionals with the finest medical solutions for their patients. Device Technologies continues to grow with HQ based in Sydney representing over 200 trusted brands, along with over 1000 highly skilled staff located across ANZ and South East Asia.
Our high-performance culture focuses on empowerment, goal attainment, productivity, continuous improvement, developing leadership capability, and a superior workforce.
We are rapidly growing our medical device distribution business in the South-East Asia region and now offer to have an exciting opportunity in Singapore.
We are seeking a passionate team player to join our South-East Asia Regulatory Affairs and Quality Assurance (RAQA) team. This is the perfect role for someone who has experience in the regulation of medical devices and is looking to gain greater exposure and experience in a multinational, multidisciplinary company.
This exciting role will be responsible for the registration and compliance of all Therapeutic Goods distributed in South-East Asia. They will work closely with operational and sales teams in a dynamic environment to ensure quality and customer needs are met. They will collaborate with local regulators as well as partner manufacturers to ensure the medical devices we distribute meet the highest of quality, safety, and efficacy standards.
At Device Technologies, our values are linked to four key areas of our business: Innovation, Collaboration, Ownership, and Good Business. Resonating with our values and the care we have for our people, you will use your technical and problem-solving skills to work amongst cross-functional teams to launch new products in the region.
You are a problem-solving, high performer who adapts quickly to change and enjoys working with a broad range of medical device product specialities. You are detail focussed and driven by deadlines, understanding the importance of prioritising your focus to meet business and customer needs. You are a great communicator who can explain regulatory requirements and processes in non-regulatory terms.
What you will be doing:
- Lodge regulatory applications and ensure compliance for your specific portfolio of medical devices, all classes, and types
- Obtain licensing and ensure compliance with other regulatory requirements for specific product types in your portfolio, such as radiocommunications, radiation, chemicals/SDS, import/export permits, etc.
- Deliver good business results through collaboration, ownership, and innovation
- Ensure timely responses to audit requirements and customer enquiries
- Ensure accuracy and currency of records and regulatory information held in databases
- Investigation, resolution, and release of quarantined goods and quality issues
- Liaison with internal and external customers
- Internal regulatory review and approval of new products before supply commences
- Assisting in internal audits and quality documentation
- Proven knowledge of, and experience in, the relevant local regulatory environment
- 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
- Tertiary qualification in relevant field (generally Science, Biomedical Engineering, etc.)
- Experience using SharePoint, SAP and Adobe Professional
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 Sterling RISQ 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.
Read about Life at Device on our careers webpage - Device Technologies
Read our article on How To Prepare For An Interview With Device Technologies | LinkedIn