New role - Regulatory Affairs and Quality Associate – Medical Devices
A Quality and Regulatory Affairs Associate is required for an exciting emerging global Medical Devices company in Sydney.
Summary about this job
Pharmaceuticals & Medical Devices
Company: i-Pharm Consulting Australia Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-3597-7246
Fax: +61-7-4120-9012
E-mail: n\a
Site: n\a
Detail information about job New role - Regulatory Affairs and Quality Associate – Medical Devices. Terms and conditions vacancy
You will be supporting a successful and specialist portfolio of devices. Working in a truly collaborative working culture.
ROLE/DESCRIPTION
- regulatory submissions
- new sponsorship registrations
- Regulatory liaison for international matters relating to product file compliance / labelling
- maintain regulatory registrations
- Broad based Quality Systems Management role supporting management
- Maintain Quality Management system
- management of product quality process for ANZ but will evolve into a global role
- exciting and passionate team
- REQUIREMENTS
- Life sciences degree (pharmacy preferred)
- Experience with TGA & Medsafe
- ISO 9001 / 13485 knowledge
- Regulatory product submissions / TGA and Medsafe
- Electronic QMS in a medical device setting
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
www.i-pharmconsulting.com
TO APPLY
If you would like to discuss this vacancy further, please call Senior Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email [email protected]. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
KEY WORDS
Senior Quality Assurance Associate, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Regulatory Associate, Senior Regulatory Associate, Submissions/Documentation, QMS, CAPA, ISO 13485.