Senior Regulatory Affairs Specialist

5 months ago

Sydney, Australia Arthrex Full time

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™.

Senior Regulatory Affairs Specialist

Benefits & Highlights:

  • Hybrid work arrangement plus competitive base salary + bonus
  • Annual cash allowances for health insurance & wellness
  • Excellent leadership, mentoring support with ongoing training & development
  • Scope: ANZ
  • Excellent ongoing training & development
  • Great reward and recognition programs

This role will ideally suit those who have a few years of Regulatory Affairs experience specifically dealing with Orthopaedic or Medical Device Products. Pharmaceutical experienced Regulatory Affairs will not be transferable to this role.

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
  • Reviews and approves marketing and advertising materials to ensure compliance
  • Participates and provides support in cross-function collaboration on new product and country launches
  • Communicate with regulators on submission projects
  • Prepares reimbursement application documents
  • 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

About the Requirements

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 or orthopaedic
  • Working experience with class III medical device submission is desirable
  • 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.

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