* Competitive base salary+ Corporate Bonus
* Health & Wellness benefits provided + Onsite Parking
* Excellent leadership, mentoring support with ongoing training & development
* Join a Global Medical Multinational
This role will see your familiarity and experience interacting with the Prescribed List shine through. You will come from a background where you already have some experience interacting with Australia's Prescribed List and this role will see you take greater focus in your career towards RA Submissions and Reimbursement with a focus on Medical Devices and Orthopaedics.
About the Role
In this role you will be responsible for the daily operations of regulatory affairs and assuring regulatory submission compliance. You will generate and manage submission documents for new products or changes to existing regulatory submissions.
* Write and submit regulatory documents for the ANZ market
* Communicate with regulators on submission projects
* Prioritise and organise multiple projects and competing priorities for efficient use of time
* Regularly maintain and update product registration and listing databases
* Change control of already-approved products including regulatory submissions
* Keep abreast of latest updates from the TGA and MEDSAFE and ensure that the company is aware, ready and able to comply with the necessary regulations
* IT support for warehouse management (scanner and printers), where applicable.
* Responsible for telephone and network socket patch management, where applicable.
* Participation in the continuous improvement of existing and new helpdesk processes.
* Collection and administration of documentation.
About You
This specialist position will suit an experienced RA professional from within the medical devices industry.
* Minimum 2+ years of RA experience within a medical device company
* Prescribed List submission and reimbursement experience is a must
* Clear knowledge and understanding of TGA and MEDSAFE regulations
* Bachelor's Degree required, preferably in a Science or Engineering discipline.
* Strong interpersonal, English oral and written communication skills required.
* Ability to work in fast paced environment and handle multiple tasks and requests.
* Ability to comprehend orthopedic technical/engineering/medical terminology or can reference literature for understanding.
About Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Arthrex Australia & New Zealand is proud to be Great Place to Work Certified based on feedback from our dedicated and growing team. We are renowned in our industry for our positive culture, integrity, leadership, and inclusivity.
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