New position on Seek

Post- Market Surveillance Manager

PolyNovo LimitedMore jobs from this company

Post- Market Surveillance Manager

About Us

At PolyNovo we are driven by improving the outcomes of patients through development and provision of the best surgical solutions possible.

We develop innovative medical devices utilising the patented bioabsorbable polymer technology Novosorb®.

We recently expanded our manufacturing facility and headquarters in Melbourne, establishing high-quality processes, enabling product innovation and preparing for growth.

Notable Achievements:

• ASX 200 Company
• Australian Biotech Company of the year 2019
• FDA, TGA, CE Mark (EU) registration
• We sell directly to the US, UK, Australia, NZ, and Singapore

The Opportunity

As an experienced and highly developed Post- Market Surveillance Manager, you will establish and maintain a longitudinal study of the market in the form of the Post-Market Surveillance System (PMS).

Your key responsibilities will include, but are not limited to:

• Process owner of PMS activities at the site
• Manage the system to ensure continued compliance
• Identify potential system gaps and areas of opportunity
• Advise updates to the system based on updated or newly released information and policies
• Coordinate PMS procedures and documentation in compliance
• Support data collection, analysis and risk-benefit evaluations
• Compile, analyse and report on post-production information
• Track execution of PMS plan according to requirements; report to management on the status of deliverables

Skills & Qualifications

• Unrestricted Australian Work Rights (i.e. Permanently with no restrictions)
• Qualifications in Medical and Health Sciences or Medical/Health Professional qualifications – preferably a Masters or PhD
• A minimum of 5 years’ experience in drug or medical device industries
• Clinical research experience including at least two years in Post- Market Surveillance
• Experience supporting clinicians in an operating room setting
• Current knowledge of Medical Device Regulation (EU) 2017/745 and FDA MDR
• Knowledge of the design, development and clinical assessment of medical devices
• Understanding of the following: ISO13485; 21CFR820, and ISO14971
• Highly developed technical writing/editing skills

If you do not meet the above role requirements you will not be considered.

Apply!

If you have the skills, qualifications and mindset to make this truly rare opportunity to join a leading Australian Biotech company, then click "apply" via SEEK and attach your CV and Cover Letter.

We look forward to meeting you!

polynovo.com.au