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Senior RAQA Associate
- Bangkok, Thailand
- Permanent - 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…
Are you passionate about Medical Device Regulatory Affairs and Quality Management Systems? Join our growing RAQA team and play a key role in supporting regulatory compliance, market access, and quality excellence across Thailand and the Asia region.
As a Senior RAQA Associate, you will be responsible for driving regulatory submissions, maintaining compliance with local regulations and quality requirements, and partnering with cross-functional stakeholders to support business growth. This role offers the opportunity to work in a dynamic environment with exposure to innovative medical technologies and regional regulatory activities.
Key Responsibilities:
- Manage medical device/ cosmetics registrations, renewals, and regulatory compliance activities with the Thai FDA.
- Maintain and support the Quality Management System (QMS) in accordance with ISO 13485 and company requirements.
- Assess product complaints, adverse events, and field actions, ensuring timely regulatory reporting where applicable.
- Support audits, inspections, supplier quality activities, and continuous improvement initiatives.
- Partner with cross-functional teams and external stakeholders to provide regulatory guidance and support business operations.
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.
Our ideal candidate for this role aligns with these values.
Experience required:
- Minimum 3-5 years' relevant Regulatory Affairs and/or Quality Assurance experience within the medical device or IVD industry, including demonstrated experience supporting or mentoring team members;
- Demonstrated knowledge and practical experience in Quality Management Systems, including ISO 13485 and/ or equivalent and post-market requirements as relevant to the responsibilities of the role;
- Knowledge of, and experience in, the relevant local regulatory environment;
- Excellent attention to detail;
- Excellent organizational skills;
- Excellent communication skills, both written and oral in English and local language;
If you are looking for an exciting opportunity to advance your RAQA career and make a meaningful impact in the healthcare industry, we would love to hear from you.
Apply now and become part of a team committed to quality, compliance, and patient safety.
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.
Agency Disclaimer
Device Technologies does not accept unsolicited resumes from recruitment agencies or third parties. In the absence of a current, written and executed recruitment agency agreement, any resumes submitted to Device Technologies will be deemed unsolicited, and no fees or charges will be payable. Device Technologies reserves the right to engage, interview or employ any candidate submitted in this way without incurring any obligation to the submitting agency or third party.