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…
This is a great opportunity to be part of the pioneer team in Indonesia to set up and build up the Indonesia entity of fast-growing medical device distribution company.
Key Responsibilities:
- Collaborate with RAQA Management and Business Management to ensure effective and timely regulatory applications in Indonesia
- Assess requirements for allocated product or product range to ensure complete regulatory compliance in Indonesia
- 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 Indonesia
- 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 CDAKB certification
- 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 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:
- 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
- Have obtained CDAKB training proven by the certification of CDAKB
- Bachelor’s degree in relevant field (generally Science, Biomedical Engineering, etc.)
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.
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