Senior RA Associate - Medical Devices
Job no: 493219
Work type: Permanent - Full time
Location: Sydney
Categories: Regulatory Affairs & Compliance
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…
You will be responsible for a portfolio of medical devices working closely with internal and external stakeholders to ensure a high level of quality, safety and efficacy is assured throughout the life cycle. You will work with cross-functional internal teams to solve problems related to regulatory affairs in the supply chain at the same time as using your exceptional relationship skills with ANZ regulators, the TGA and Medsafe, to demonstrate compliance of new products with local requirements.
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
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.
Advertised: AUS Eastern Standard Time
Application close: AUS Eastern Daylight Time
Apply now