Aus - Vigilance & Pms Coordinator (Post Market

2 weeks ago

Pymble, Australia Corin Group Full time

About the job
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.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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