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Job Details

Quality and Regulatory Lead - Medical Devices

Company: i-Pharm Consulting
Location: Sydney
Reference: #11572
Closing Date: 24 Jan 19
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

JOB SUMMARYA Quality and Regulatory Lead is required for a small but growing medical devices company building their global operation from Sydney.The company has recently had a large capital injection globally providing an exciting phase in their growth.

Requirements:

JOB TITLE

Quality and Regulatory Lead - Medical Devices - Sydney Based



JOB SUMMARY

A Quality and Regulatory Lead is required for a small but growing medical devices 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

* Broad based Quality and Regulatory hybrid role
* Lead for functions for ANZ
* Reporting into ANZ Operations and Quality Director
* Regulatory Submission to ANZ
* Product Listings
* Maintain Quality Management system in line with ISO13485, GMP,
21CFR820 and other standards relevant to the design, development, manufacture and distribution of a product.
* Document Control
* Configuration Management
* Provide oversight on CA/PA related activates

REQUIREMENTS

* Life sciences degree (pharmacy preferred)
* Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
* Experience with TGA and Medsafe
* Reimbursement experience
* ISO 13485 knowledge
* People management would be a bonus
* 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 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.

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.

Apply for this job: Quality and Regulatory Lead - Medical Devices

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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