Regulatory Affairs Manager
We are a global medical device’s organisation and expanding our team here in Australia hence looking for a Regulatory Affairs Manager to join our team.
A multifunctional role you will hold responsibility to deploy, maintain, and execute a world class medical device Regulatory Affairs system. You will ensure our products are compliant and support the business by maintaining and improving on current quality and regulatory practices and improving the regulatory side of our business. You are a high energy, results-oriented professional with excellent collaboration and project management skills and demonstrated product design, manufacturing, and supply chain process expertise.
Your role includes:
- Executing the pre-market process in order to secure compliance and thereby achieve TGA/Medsafe product approvals.
- Execute the post-market process in order to secure compliance and continuous product approvals
- Prepare supporting documentation to manage submissions and gain approvals.
- Ensure all relevant local and international requirements are met so products are compliant
- Ensure ISO9000/13485 standards are implemented and maintained
- Acts as a point person for quality and regulatory interactions
- Provide expertise and guidance in interpreting US and foreign governmental regulations, agency guidelines, and in
- Promote internal/corporate policies to ensure compliance is maintained and results are achieved.
- Liaise with our global Regulatory Affairs/Quality management team to ensure ANZ conforms to global directives.
- Maintaining and development of local Quality Management System
- Ensure customer complaints are dealt with promptly.
- Participate in Quality Assurance activities (e.g. bi-monthly APAC update calls, conference as required, etc.)
- Non-conformance and corrective action reporting and follow-up
To ensure success in this role you will have:
- Bachelor of Science degree in engineering or a scientific/technical discipline
- TGA/Medsafe device regulation experience
- Six Sigma Black Belt or Master Black Belt desired.
- Minimum 7 years as a Regulatory/Quality Affairs Manager within medical devices
- Strong working knowledge of regulatory affairs and hands-on experience with regulatory planning, submission preparation and discussions with regulatory authorities.
- Experience with a Quality Management System such as ISO 9001
Frontline Health is a trusted advisor and recruitment partner to the Healthcare sector in Australia. We recognise that our role is to work closely with our clients and candidates to help secure outstanding talent with the appropriate skill set and fit.
Front of Mind, Frontline Health - specialist recruiters to the healthcare industry
To apply online, please click on the apply button and attach your CV and Cover Letter preferably in Word format
Alternatively, for a confidential discussion, please contact Connie Fitzpatrick on +61 2 8315 2117, quoting Ref No. 161752. Please continue to check our website for other positions available.