Senior Regulatory Affairs Specialist, ANZ

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team, at a global medical device company, focused on Helping Surgeons Treat Their Patients Better™.

Benefits And Highlights:

• Attractive Basic Salary and incentive structure
• Annual cash allowances for health insurance & wellness
• Excellent leadership, mentoring support with ongoing training & development
• Great reward and recognition programs
• Location: Frenchs Forest (3 days per week required in the office) + Hybrid

About The Role:

In this role, you will oversee the day-to-day operations of regulatory affairs, ensuring full compliance with regulatory submission requirements. You will be responsible for preparing and managing documentation for new product submissions and updates to existing approvals.

Key Responsibilities:

• Prepare and submit regulatory documentation for the Australia and New Zealand (ANZ) market
• Review and approve marketing and promotional materials to ensure regulatory compliance
• Collaborate cross-functionally to support new product launches and market expansions
• Liaise with regulatory authorities regarding submission projects and approvals
• Develop and submit reimbursement applications
• Effectively manage multiple projects and competing priorities to optimize time and resources
• Maintain and update product registration and listing databases on a regular basis
• Manage change control processes for approved products, including related regulatory submissions
• Monitor updates from TGA and MEDSAFE, ensuring the organization remains informed and compliant with evolving regulations

About The Requirements

This specialist position will suit an experienced RA professional from within the medical devices industry.

• Bachelor’s Degree required, preferably in a Science or Engineering discipline. 
• Minimum 3+ years of RA experience within a medical device company
• Exposure to Orthopaedic products would be advantageous
• Working experience with class III medical device submissions
• Clear knowledge and understanding of TGA and MEDSAFE regulations
• 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 orthopaedic 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.

Great Place to Work Certified 2024 - 2025:

Arthrex Australia and 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. Join us at Arthrex, where your career can truly thrive.

Applicants must have full Australian work rights to be considered at this time.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.