Vigilance Complaints Associate - Sydney
Corin, Australia
Job Description
About the job
Corin Australia is looking for an experienced and motivated Vigilance amp; Complaints Associate to join the Optimized Ortho (Technology) division of our growing team. This is a full-time, ongoing position and will be based out of our Sydney office located in Pymble, close to public transport. At Corin we recognize that we are living and working in a constantly changing, fast-paced world and we are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. This includes options to flexibly shift your work times and work from home.
We are a small, but rapidly growing company, so we are looking for individuals who want to grow, develop, learn and contribute to our team. You will pride yourself on your ability to work collaboratively and independently in a cross-functional team environment. A positive attitude to change and a passion for improving patient lives is essential.
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 amp; 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
Requirements
On your first day, we'll expect you to have:
- 2 -3 years prior experience in a regulatory role within the medical device industry
- Bachelor’s degree in Engineering, Health science or equivalent
- Proficiency with technical communication and related software
- Prior experience with complaint handling, MDR/Vigilance reporting
- Outstanding organisation/time management skills
- 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.
- Excellent organisational and interpersonal skills
- Customer and quality focus
- Exceptional attention to detail
- Self-directed and results orientatedExcellent written and oral communication skills
- Prior medical device experience or experience working within a regulated environment (bonus points for exposure to 62304 or 13485)
Benefits
More About Our Benefits
In return we will offer you a competitive remuneration and benefits package, opportunities for growth and development, within a dynamic and supportive team environment. At Corin we believe that to be successful at work, you need to enjoy what you do. You have to be rewarded for your efforts and motivated to keep going even when the pressure's on. We will help you to play to your strengths and develop and build a career you can be proud of.
More About Corin
As a leader in orthopaedic innovation, Corin has pioneered several landmark orthopaedic developments since its foundation in 1985. We are very proud that we have been able to improve the quality of life of thousands of patients around the world through these ground breaking products, and believe this heritage distinguishes Corin within the global orthopaedic market. Our technologies enable surgeons to perform patient-specific procedures and gain a unique level of insight and understanding allowing them to easily monitor progress and achieve the most positive results. Improving patient satisfaction is at the centre of everything we do by delivering personalised technologies that optimise our clinically proven joint replacements.
How to Apply
If you are looking for a rewarding and exciting opportunity to be part of a talented global team that positively impact lives,