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Post-market Vigilance Specialist
3 months ago
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.
The opportunity
This is an excellent opportunity for an experienced medical device professional to join the Post Market team, performing various functions including recall reporting, tracking, customer communications and process delivery.
Key Responsibilities:
- Issue and track recall and field action customer communications.
- Prepare reports on Recall/ Field Action progress and completion.
- Provide correspondence to regulatory agencies.
- Ensure accurate and timely communications with manufacturers.
- Monitor and facilitate product return/Destruction for Recalls.
- Provide regulatory vigilance guidance and/or training to others.
- Interface with Product Specialists to gather additional information required for Recalls and Field actions.
- For reportable events, you will be expected to ensure reports are wellwritten and submitted to the applicable agency within the required timeframes.
- Championing continuous improvement action plans.
- Develop and maintain excellent working relationships with government departmental staff, suppliers/vendors, and internal DT staff.
- Coordinate specific projects relating to postmarket vigilance.
- Provide support to the RAQA department as required.
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.
Experience required:
- Bachelor's degree in a technical or scientific discipline or equivalent education, experience, training
- 2+ years of Quality and/or Regulatory experience in a medically regulated and technical environment
- Strong interpersonal skills
- Strong computer skills essential, such as industryrecognized complaint management systems, SharePoint, and MS Office Suite
- Familiarity with medical terminology
- Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor.
- Analytical and problemsolving skills
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 interview process by management to qualify fit for role and prior to any offer._
