Senior Regulatory Affairs Associate-Medical Devices - R&D

JOB TITLE

(Senior) Regulatory Affairs Associate - Medical Devices - Adelaide Based

JOB SUMMARY

A (Senior) Regulatory Affairs Associate is required for an exciting growing medical devices company building their global operation from Melbourne.

The company has recently had a large capital injection globally providing an exciting phase in their growth.

ROLE/DESCRIPTION

• driving the execution of submissions mostly to TGA, Medsafe but also further down the line in ROW & US FDA
• Manage the document control function
• Product approval
• working closely with Marketing, R & D and post market surveillance
• full exposure to working on market commercial entry
• work closely with scientists / engineers
• maintain regulatory registrations
• working through product recalls
• Regulatory liaison for international matters relating to product file compliance / labelling

REQUIREMENTS

• Life sciences degree (pharmacy preferred)
• Experience with TGA & Medsafe
• Global product submissions experience
• Worked previously supporting manufacturing and R & D previously
• TGA, Medsafe, ROW, US FDA
• ISO 9001 / 13485 knowledge
• Electronic QMS in a medical device setting (ISO 13485)

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 tdesborough@i-pharmconsulting.com. 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

Quality Engineer, Quality Manager, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.

Principal Consultant, Senior RA Associate, Senior Regulatory Affairs Associate, Regulatory Affairs Associate, Regulatory Affairs Manager, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, Regulatory Training, Regulatory Trainer, Renewals.