Regulatory Affairs Coordinator - Entry Level

Device Technologies; Sydney; On-site; AUD 55,000 - 70,000; Full time

Job summary

Device Technologies in Northern Beaches, NSW, AU seeks an entry level Regulatory Affairs Coordinator to support regulatory compliance for locally procured products. The role includes assisting with SAS approvals and maintaining documentation under supervision of the RAQA team.

Recent graduates or early career professionals will receive full training and support to grow in regulatory affairs, aligning with our commitment to quality and patient safety.

Qualifications

• Experience in Regulatory Affairs or related internship is desirable.

Skills

Communication

Organisational skills

Attention to detail

Problem-solving

Education

Tertiary qualification in medical science, engineering or related field

Tools

Microsoft Office

Job description

Regulatory Affairs Coordinator - Entry Level Device Technologies•Northern Beaches, NSW, AU

Job Description

Regulatory Affairs Coordinator - Entry Level

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 rare entry level opportunity in Medical Device Regulatory Affairs with a global company. The successful applicant will be provided full support and training to take responsibility for regulatory compliance of locally procured products. In addition, ensuring documented approvals and records are in place for unapproved therapeutic goods supplied in Australia through the TGA's Special Access Scheme (SAS). If you are a recent graduate or early in your career, take this opportunity to work with a world class RAQA team, a great start to your regulatory affairs career.

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.

The ideal candidate will have strong communication and problem‑solving skills, with a keen eye for detail and a passion for ensuring provision of high quality, safety and effective devices to healthcare providers and patients. You will make a difference in patient quality of care in this role by ensuring products Device Technologies supply meet safety standards. You will be highly organised and self‑motivated to perform well in this junior role.

Experience required:

• Tertiary qualification in medical science, engineering or related field (suits recent graduate)
• Formal training or experience in Regulatory Affairs, or completion of a related internship is not mandatory but highly desirable
• Experience in customer service, corporate or healthcare environment is desirable
• Excellent communication and organisational skills
• Good understanding of medical terminology
• Proficiency in Microsoft Office, including Outlook, Teams, Word, Excel and PowerPoint

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.