
Regulatory Affairs Specialist
1w1 week agoArthrex
Sydney, AU · Full-time · A$100,000 – A$140,000
About this role
This role leverages your familiarity and experience interacting with the Prescribed List. You will focus on RA Submissions and Reimbursement for Medical Devices and Orthopaedics. Responsible for daily operations of regulatory affairs and assuring submission compliance, you will generate and manage documents for new products or changes.
Write and submit regulatory documents for the ANZ market while communicating with regulators on submission projects. Prepare reimbursement application documents and prioritize multiple projects for efficient time use. Maintain product registration databases and handle change control for approved products.
Join Arthrex, a global medical device company pioneering arthroscopy with over 1,000 innovative products yearly. Arthrex Australia & New Zealand is Great Place to Work Certified based on team feedback. Renowned for positive culture, integrity, leadership, and inclusivity.
Benefit from excellent leadership and mentoring support with ongoing training and development. Work onsite with parking provided in French’s Forest, NSW. Advance your career in a family business culture committed to quality for surgeons and patients.
Requirements
- Minimum 2+ years of RA experience within a medical device company
- Prescribed List submission and reimbursement experience
- Clear knowledge and understanding of TGA and MEDSAFE regulations
- Strong interpersonal, English oral and written communication skills
- Ability to work in fast paced environment and handle multiple tasks
- Ability to comprehend orthopedic technical/engineering/medical terminology
Responsibilities
- Write and submit regulatory documents for the ANZ market
- Communicate with regulators on submission projects
- Prepare reimbursement application documents
- Prioritise and organise multiple projects and competing priorities
- Regularly maintain and update product registration and listing databases
- Manage change control of already-approved products including regulatory submissions
- Keep abreast of latest updates from the TGA and MEDSAFE to ensure compliance
Benefits
- Base salary + Corporate Bonus
- Health & Wellness benefits provided + Onsite Parking
- Excellent leadership, mentoring support with ongoing training & development
- Join a Global Medical Multinational
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