Regulatory Affairs Specialist - Medical Devices in Sydney

Regulatory Affairs Specialist - Medical Devices in Sydney

Sydney Temporary 50715 - 61985 $ / year (est.) On-site
H

At a Glance

  • Tasks: Manage regulatory submissions and ensure compliance for innovative medical devices.
  • Company: Leading health and aged care professionals in Sydney.
  • Benefits: Competitive pay, flexible hours, and opportunities for professional growth.
  • Other info: Exciting contract role with potential for future opportunities.
  • Why this job: Join a dynamic team making a difference in healthcare technology.
  • Qualifications: Experience in regulatory affairs and knowledge of medical device regulations.

The predicted salary is between 50715 - 61985 $ per year.

Health and Aged Care Professionals in Sydney, NSW seeks a Regulatory Affairs professional for a contract role spanning regulatory submissions, technical documentation, and lifecycle regulatory activities for software-based medical devices.

You will partner with cross-functional teams to ensure compliance with TGA, EU MDR and international regulations, manage CAPAs, labeling reviews, and post-market surveillance while supporting field actions and recalls as needed.

Regulatory Affairs Specialist - Medical Devices in Sydney employer: Health and Aged Care Professionals

Join a leading Australian business in the therapeutic goods sector, where you will play a pivotal role as a Regulatory and Quality Manager in Melbourne. With a strong focus on employee development, a collaborative work culture, and the opportunity to shape compliance processes, this position offers a rewarding environment for those looking to make a significant impact. Enjoy competitive remuneration, a supportive team atmosphere, and the chance to work closely with senior leadership and international suppliers, all while contributing to the health and safety of the community.

H

Contact Details:

Health and Aged Care Professionals Recruitment Team

We think you need these skills to ace Regulatory Affairs Specialist - Medical Devices in Sydney

Regulatory Submissions
Technical Documentation
Lifecycle Regulatory Activities
Compliance with TGA
EU MDR
International Regulations
CAPA Management