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SalaryHighly successful Innovative medical diagnostics R&D Manufacturer is recruiting a Regulatory and Clinical Manager to manage Regulatory operations.
This role is standalone currently with a view to down the line perhaps managing people.
The management team invested in this company is top tier with great momentum opening up pathways in a number of regions already.
They are looking for someone who will work at the Global HQ in Melbourne and enable the organisation to branch out into other countries of the world.
Reporting into the CTO.
The company is in a strong position and well funded, therefore will suit an achiever who wishes to make an impact and like fast pace.
This covering influence will not just help corporate deliverables to be met, but also provide more deserving patients around the world the access they need to the company's innovative medical technology.
This role will be supporting by external consultants global however is a global remit.
Someone who will relish in continuous company growth and like a fast paced environment in the truest sense. This company is well established with HR processes and training programs.
A genuinely exciting time for this health technology research, patients and company alike.
ROLE/DESCRIPTION
- full line management of small team
- driving the execution of local submissions
- MDD/MDR Conformity Assessment
- IVDR
- Identify regulatory opportunities that facilitate commercial market entry
- Manage the document control function
- Product approval
- Work closely with engineering
- FDA Part 820
- GCP Guidelines as they research new products in development
- working closely with Marketing, R & D and post market surveillance
- full exposure to working on market commercial entry
- marketing and distribution
- maintain regulatory registrations
- working through product recalls
- Regulatory liaison for international matters relating to product file compliance / labelling
- Life sciences degree (pharmacy preferred)
- Experience with TGA & Medsafe
- Line Management experience needed
- Product submissions experience
- ISO 9001 / 13485 knowledge
- Line management is a pre requisite
- Electronic QMS in a medical device setting (ISO 13485)
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 Executive 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.
