Regulatory Affairs Manager - Diagnostics

1 day left

Location
Sydney, Australia, New South Wales
Salary
Negotiable
Posted
31 May 2021
Closes
14 Jun 2021
Ref
#11572
Contact
Tom Desborough
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

JOB TITLE

Regulatory Affairs Manager - Medical Devices and Diagnostics - Sydney Based

JOB SUMMARY

A Regulatory Affairs Melbourne is required for an exciting growing medical devices and diagnostics company building their global operation from Sydney.

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

ROLE/DESCRIPTION

  • full management of regulatory work with expanding scope of work on a global scale
  • Regulatory Affairs strategy
  • 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
  • Regulatory work supporting R&D operations
  • Regulatory Strategy
  • 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.

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