Regulatory Affairs Associate
ResApp Health is developing digital healthcare solutions to assist doctors and empower patients to diagnose and manage respiratory disease. We are building a small team to combine cutting-edge technology with world-class science to deliver breakthrough mobile health solutions and solve real healthcare problems. Our first software-as-a-medical-device product, ResAppDx-EU, is CE Marked and TGA approved as a class IIa medical device, and we have a number of additional medical device products in our development pipeline. We are looking for a regulatory affairs professional to join our fast growing team. The successful candidate will help manage our regulatory submissions and ensure regulatory compliance for multiple products globally.
ResApp is a well-funded startup, listed on the ASX and based in Brisbane, Australia.
- Act as liaison with regulatory authorities such as EU Notified Bodies, TGA, MHRA (UK) and US (FDA).
- Assemble and maintain design history files, technical files, device master records and other regulatory documentation.
- Responsible for the review of change controls to ensure any required regulatory change notifications/reporting or new submissions are carried out.
- Responsible for the review of complaints and participating in risk assessments to determine regulatory vigilance requirements.
- Responsible for regulatory review of document changes, deviations, labelling and printed materials as required to ensure all necessary regulatory requirements are met.
- Perform research and assist in defining regulatory and clinical strategies.
- Bachelor’s degree in law, pharmacy, engineering or medicine.
- A minimum of 2 years of related medical device experience.
- Knowledge of regulatory requirements (TGA, CE and/or FDA).
- Understanding of quality systems.
- Proven track record of organising work-load and activities to meet required deadlines.
- Excellent written and verbal communications skills with the ability to work collaboratively.
To apply please send a cover email and a copy of your resume to firstname.lastname@example.org.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2020 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries.