Senior RA Associate - Medical Devices

at  Device Technologies Australia

Sydney, New South Wales, Australia -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate14 Nov, 2024Not Specified15 Aug, 20243 year(s) or aboveRegulatory Affairs,Supply Chain,Regulatory SubmissionsNoNo
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Description:

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.

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.
You will be a self-motivated problem solver who makes valuable connections in all aspects of the business to understand customer and regulator needs, matching the two to provide access to devices in the target region. You are driven by deadlines and take pride in exceeding targets at the same time as being passionate about the delivery of high-quality healthcare products to Australian and New Zealand patients.

Experience required:

  • 3-5 years Australian experience working with the TGA in medical device regulatory submissions for Class I-IIb
  • Working knowledge of the New Zealand medical device requirements
  • Experience solving regulatory related problems in the supply chain and working with cross functional teams representing regulatory affairs on projects

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:3.0Max:5.0 year(s)

Information Technology/IT

Pharma / Biotech / Healthcare / Medical / R&D

Software Engineering

Graduate

Proficient

1

Sydney NSW, Australia