Quality and Regulatory Associate-Medical Devices-Manufacturing

JOB TITLE

Quality and Regulatory Affairs Associate - Medical Devices - Sydney Based

JOB SUMMARY

A Quality and Regulatory Affairs Associate is required for an exciting growing medical devices company building their ANZ operation from the Sydney office.

The company has a unique range of complex medical devices that are designed to provide the patient with care when they need it most. The product range is growing as well as the complexity aligned with Orthopaedics.

ROLE/DESCRIPTION

• Broad based Regulatory role
• Reporting into the US
• Regulatory Submissions supporting ANZ
• Conformity Assessments
• Product Listings for Global Market
• 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
• Global listings including FDA
• OHS experience a plus but not a pre-req
• Reimbursement experience
• ISO 13485 knowledge would be plus
• Electronic QMS in a medical device setting
• visa / eligibility to work in Australia

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, Ortho