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Regulatory Affairs Associate

4 months ago

กรงเทพมหานคร, Thailand Device Technologies Australia Full time

**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 rapidly growing our medical device distribution business in Asia region and now offer have an exciting opportunity in Thailand.

We are seeking a passionate team player to join our 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 registration and compliance of all therapeutic Goods distributed in 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.

**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.

You are a problem solving, high performer who adapts quickly to change and enjoys working with a broad range of medical device product specialties. You are detail focused and driven by deadlines, understanding the importance of prioritizing 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**:

- 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

**Experience required**:
**Essential**
- 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

**Desirable**
- Tertiary qualification in relevant field (generally Science, Biomedical Engineering etc.)
- Experience using SharePoint, SAP and Adobe Professional

**Interested?**

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.
- 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 intervie