Vigilance & Pms Coordinator (Post Market

2 weeks ago

Pymble, Australia Corin Group Full time

Corin Australia is looking for a Vigilance & PMS Coordinator to join the Vigilance division of our business. This is a full-time, ongoing position and will be based out of our Sydney office located in Pymble, close to public transport. This role is ideal for a recent graduate interested in the medical device field.
About the company
Since inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics.
We offer a unique combination of clinically-proven hip and knee solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever.

**What you will be doing**:

- Inputting, analysing and reviewing all reactive post market data received from market
- Seeking information as necessary to ensure all relevant information is made available, recorded, assessed, and processed in a timely manner
- Performing vigilance reporting and responses to regulatory bodies to ensure regulatory compliance in a timely manner in line with departmental objectives
- Ensuring complaint investigations are delivered in a timely manner and that investigations are adequate, accurate and detailed
- Performing tasks to obtain adequate information to ensure proper documentation and closure of each complaint
- Collaborating with appropriate departments and Global Vigilance to assist with the resolution of product issues in the field
- Assisting with the preparation of Post Market Surveillance Plans and its associated reports such as the Periodic Safety Update Reports
- Maintaining a working knowledge of regulations and standards related to post-market surveillance and quality
- Assisting with Post Market Surveillance training to support coaching, mentoring and continuous development, with an aim to increase compliance for post market reporting
- Monitoring Post Market Surveillance data, identify & investigate post market problems and develop remedial actions to minimise risk to patient or user
- Monitoring product performance post market and recommend any improvements suggestions

**To be successful in this role you will need to have**:

- Bachelor’s degree in Engineering, Health science or equivalent
- Exceptional attention to detail
- Outstanding organisation/time management skills
- Proficiency with technical communication and related software
- The ability to work well autonomously and as part of a team
- An ability to adapt and respond in a fast-paced, and changing work environment.
- Customer and quality focused
- Excellent written and oral communication skills
- Prior medical device experience or experience working within a regulated environment is highly regarded, but not essential (bonus points for exposure to 62304 or 13485)

If you are interested in learning more about Corin please visit our website here.

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