Global Quality/Safety Manager – Medical Devices - ANZ based
A Complaints /Vigilance Manager is required for a fantastic Medical Devices company. Sydney based - manufacturing environment.
Summary about this job
Pharmaceuticals & Medical Devices
Company: i-Pharm Consulting Australia Pty Ltd
Location: Auckland
Work type: Full Time
Salary: n\a
Phone: +64-4-405-1291
Fax: +64-7-578-2089
E-mail: n\a
Site: n\a
Detail information about job Global Quality/Safety Manager – Medical Devices - ANZ based. Terms and conditions vacancy
ROLE/DESCRIPTION
- Medical device complaint strategy end to end reporting
- Complaints and CAPA reporting
- Line Management of mid size global team
- Detailed understanding of 21 CFR 820 / FDA requirements
- Manage the document control function
- Understand how to work in a cross functional and global company
- Continuous Improvement working closely with Quality Assurance and IT Systems
REQUIREMENTS
- Life sciences degree (pharmacy preferred)
- Experience with TGA & Medsafe
- ISO 9001 / 13485 knowledge
- Pharmacovigilance / complaint handling in medical devices or drug development
- Strong people management is a must
- Relocation and sponsorship available for an strong overseas applicant
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
Complaints Manager, Drug Safety, FDA, 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.